Hospira sapphire pump scenarios for ed ketamine use scenario one ed the nurse receives an order to give a healthy 35 yr old, 70 kg patient 21 mg of ketamine by infusion for pain. Wireless usb adapter user manual details for fcc id stj804196001 made by hospira, inc. Hospira mednet software enhances safety at the point of care with highly customizable drug libraries that guide users and helps to protect patients by alerting to hard and soft limits, upper and lower dosing limits intended to help prevent infusion errors. Food and drug administration fda for modifications to the symbiq infusion system. This is not the first alert concerning hospital equipment cybersecurity and certainly will not be the last.
Aug 06, 2015 hospira and an independent researcher confirmed that hospiras symbiq infusion system could be accessed remotely through a hospitals network. This document and the subject matter disclosed herein are proprietary information. How to upload hospira mednet alert logs to ipi purpose statement this document is intended to assist users of hospira pumps to upload their alert log files into infusion pump informatics ipi system. The symbiq one and two channel infusers are infusion pumps intended for. Hsp, the worlds leading provider of injectable drugs and infusion technologies, and q. With its unique combination of nursefriendly features, autodefault to safety software, and. Fda warns of cyber security flaws in hospira infusion pump. System operating manual the pump performs a suite of system selftests when power is applied to approveid labeling. The symbiq system is no longer manufactured or distributed by hospira, but it is potentially available for purchase via third parties. Risks associated with each device field correction are detailed in the tables attached per pump family symbiq, plum, lpca and gemstar. Due to problems with the hospira symbiq infuser touchscreen, the device may fail to respond to user selections, register a different value than what was intended or may provide a delayed response. Hospira and q core medical sign international distribution. Fda warns of security flaw in hospira infusion pumps reuters.
Symbiq raises the bar for infusion pump technology with an innovative and usercentric approach. Hsp, a leading provider of clinical information and medication delivery technologies, today announced that the company has submitted a 510k application with the u. With remote access and elevated privileges, the symbiq infusion system can be remotely directed to perform unanticipated. Katy narlock 2242123116 manufacturer reason for recall. Hospital hardware hacking august 3, 2015 on july 31 the fda issued a safety alert encouraging health care facilities to stop using hospira symbiq pumps due to cybersecurity concerns. For use with list number 12396 franks hospital workshop. Manuals and user guides for download medpro equipment. Jul 31, 2015 hospira said in a notice on its website that it was working with symbiq customers to deploy a software update that closes access ports to the pump and includes other cybersecurity protections. Hospira symbiq community, manuals and specifications.
Hospira retains all the exclusive rights of dissemination, reproduction, manufacture, and sale. More performance, designed to meet your home infusion needs, the sapphire infusion system helps you deliv. In a notice posted to its website, the fda says hospira and the researcher have found that a cyber intruder could change the dosage of. If missing rubber stop pads were discovered they were advised to contact hospira s advanced knowledge center at 18002414002, option 4, to receive a replacement pole clamp assembly or be directed to a. View the user manual part 2 for hospira devices like symbiq one channel infusion system. How to turn on hospira symbiq infusion pump and set to pause.
Healthcare facilities are advised that any symbiq systems in use should be disconnected from the information system network. Fluid containers can be an alert sounds to allow the user. Hospira s new symbiq pumps large touch screen is well suited for an application like this. Wireless usb adapter user manual details for fcc id stj804196001 made by hospira, inc document includes user manual user manual. This training is modeled on a typical healthcare provider. Abbot labs hospira symbiq 160270470 dual channel infusion. Manufacturer specifications symbiq infusion system, hospira please note.
The terms infusion system, infuser, and devi ce are used interchangeably throughout the manual. The fda is cautioning healthcare facilities on the use of the discontinued symbiq infusion system after the manufacturer and an independent investigator determined that unauthorized users could gain access to the pump through a hospital network. Apr 04, 2011 hospira submitted the 510k application to the fda on march 31, 2011. Additionally, hospira has voluntarily stopped all new sales of its intravenous infusion pumps, except in a priority situation involving patient safety, while it addresses issues in its quality management system. For use with list number 12396 technical service manual r infusion system 43010996001 rev. Details about abbot labs hospira symbiq 160270470 dual channel infusion pump 18087. Symbiq 16026 16027 infusion pump operation manual topcon nw8 user manual. Hospira complete overview of drugs and treatments by treato. Hsp, the worlds leading provider of injectable drugs and infusion technologies, and q core medical. Nov 26, 20 hospira s longtroubled infusion pump business is dealing with another recall, earning the fdas mostsevere warning over a device malfunction the agency said can lead to serious injury and death. Hospira said in a notice on its website that it was working with symbiq customers to deploy a software update that closes access ports to the pump and includes other cybersecurity protections. Learn about hospira, its top prescription drugs and treatments from patients and trusted sources, including side effects, interactions and firsthand experiences. Usd767756s1 us29457,521 us2029457521f usd767756s us d767756 s1 usd767756 s1 us d767756s1 us 2029457521 f us2029457521 f us 2029457521f us d767756 s usd767756 s us d767756s authority us united states prior art keywords medical pump medical pump side elevational elevational view prior art date 20611 legal status the legal status. Citing hacking risk, fda says hospira pump shouldnt be used.
Hospira faces another pump recall over deadly risk. Fda asks hospitals to stop using hospira symbiq infusion. Consignees were notified of the issue via an urgent. Fda issues alert medication infusion pump hacking alert. The symbiq vulnerability was first disclosed by uscert on june 23, 2015. Software is intended for accurate, volumetric infusion of analgesic drugs by continuous or patient. Hospira infusion pumps important medical device safety.
Sapphire infusion system call for price based on a unique, patented technology that delivers precise infusing at 2. The hospira sapphire pca pump can be used for non pca infusion like ketamine infusion usually given in eds and icus. Fda warns of cybersecurity vulnerabilities with hospiras symbiq august 7, 2015 in a notice posted to its website, the fda says hospira and the researcher have found that a cyber intruder could change the dosage of the pump delivers, causing an over or underinfusion of patient therapies. These limits are based on a hospitals specific iv administration practices. Potential for the symbiq pole clamp assemblies to be missing the rubber stop pad. He expects to see a hybrid model like patient monitoring, where the user interface is on the device at bedside with some or all of the software running on a server somewhere on the network. System operating manual 9 run starts fluid delivery at the rate set by the user. Hospira gemstar infusion pump, yellow cap w p389 lock.
The lifecare pca infusion system with hospira mednet. Update 1fda warns of security flaw in hospira infusion pumps. Database contains 2 hovertech hovermatt manuals available for free online viewing or downloading in pdf. An unauthorized user could issue commands to the pump. The symbiq infuser requires users to select an entry from the drug library for all drug delivery programs. Hovertech hovermatt manuals and user guides, medical. Manufacturer specifications symbiq infusion system, hospira. Hospira symbiq infusion system vulnerability cisa uscert. None of the equipment posted for sale on is owned by medwow, should you have any questions regarding a specific item, please direct them to the appropriate seller by making use of the available communication channels on the items page. Hospira and an independent researcher confirmed that hospiras symbiq infusion system could be accessed remotely through a hospitals network. The food and drug administration on friday issued an alert warning that hospiras symbiq infusion system smart pumps could be vulnerable to hackers,a and recommended that healthcare facilities.
Figures are rendered as graphic representations to approximate actual product. Service and operating manuals pdf medpro equipment. Infusion pump therapy a guide for clinicians and hospira. Gemini alaris pc 4 volumetric infusion pump operation user manual gemstar hospira 86 87 88 operation user manual. Device field correction letter, dated 1232008, and were requested to respond appropriately to any alarm or warnings displayed by the device. Fda warns of cybersecurity vulnerabilities with hospiras symbiq. The firm is making arrangements to screen each symbiq pump in customer facilities and implement the appropriate enhancements. On september 3, 2015, hospiras common stock ceased trading on the new york. Hospira retains all the exclusive rights of dissemination, reproduction, manufacture, and. Symbiq 16026 16027 infusion pump operation manual medpro. The symbiq infusion system incorporates human factors design that provides intuitive ease of use to accelerate staff acceptance and reduce risk of programming errors. Technical service manual plum xl 1155504, 1257004 lifecare xl 1155509, 11555, 1155527, 1155529, 1155536. Class 2 device recall hospira symbiq infusion system with.
This could allow an unauthorized user to control the device and change the dosage the pump delivers, which could lead to over or underinfusion of critical patient therapies. The pump operating indicator light on the front panel flashes during pumping. Aug 03, 2015 the food and drug administration on friday issued an alert warning that hospira s symbiq infusion system smart pumps could be vulnerable to hackers,a and recommended that healthcare facilities. User manuals, guides and specifications for your hovertech hovermatt medical equipment.
Symbiq infusion system 1 2 technical service manual specific instructions for operating the device are contained in the symbiq system operating manual. On july 31 the fda issued a safety alert encouraging health care facilities to stop using hospira symbiq pumps due to cybersecurity concerns. Hospiras new symbiq pumps large touch screen is well suited for an application like this. Hospira has verified that this vulnerability only exists in the symbiq. According to hospira, during a recent service visit, the remaining symbiq infusion systems have had port 20ftp and port 23telnet closed. The combination of local pfizer and hospira entities may be pending in various jurisdictions and integration is subject to completion of various local legal and regulatory steps.
Comes with everything you see in pictures nothing more nothing less. Manual updates to each pump can be labor intensive and prone to entry error. Symbiq raises the bar for infusion pump technology with an innovative and user centric approach. Medical product service and user manual a to m for download are available here. Hospiras longtroubled infusion pump business is dealing with another recall, earning the fdas mostsevere warning over a device malfunction the agency said can lead to serious injury and death. Hospira is working closely with the fda to ensure that the symbiq submission follows all guidelines of the new 510k draft guidance for infusion pumps. Hospira identified vulnerabilities in the symbiq infusion system.
The lake forest, illinois, company declined to say how many of the. Hospira and an independent researcher confirmed that hospiras symbiq infusion system could be accessed remotely through a hospitals network, the fda said in its report. Aug 07, 2015 the symbiq vulnerability was first disclosed by uscert on june 23, 2015. As previously announced by hospira in 20, the symbiq infusion system was retired by hospira on may 31, 2015 and will be fully removed from the market by december 2015. The timeframe for fda clearance of the symbiq upgrade cannot be determined. Gemstar hospira pm 150 operation user manual gemstar hospira programming sp 86 87 88 operation user manual. Hospira and an independent researcher confirmed that hospiras symbiq infusion system could be accessed remotely through a hospitals network, an action that could potentially allow an unauthorized user to control the device and change the dosage the pump delivers, which could lead to over or underinfusion of critical patient. Hospira sapphire community, manuals and specifications. Hospira to eliminate symbiq, other pumps after may 01, 20 hospira inc. Fda warns of cybersecurity vulnerabilities with hospiras.
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