8 of the Biggest Infusion Pump Fails

  • 8 of the Biggest Infusion Pump Fails

    Their errors may have not elicited the same horror from the public as metal-on-metal hip implants or vaginal meshes. But infusion pumps have been one of the most recall-plagued medical devices in the past decade. From 2005 through 2009 alone, FDA received roughly 56,000 reports of adverse events linked to infusion pumps. In that time frame, 87 infusion pumps were recalled in the United States for safety reasons. The debacle led to more rigorous usability testing requirements for medical devices writ large. Yet Infusion pumps continue to be implicated in a substantial proportion of Class I recalls.  

    Here’s a recap of some of the most prevalent infusion pump recalls in recent memory:

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  • 1. Medtronic Consent Decree with FDA over Synchromed II Device

    It was just earlier this year that an FDA consent decree alleged that Medtronic has repeatedly failed to address manufacturing problems related to its Synchromed II implantable infusion pump. First approved in 2004, the device has sometimes had issues including inaccurately delivering medication or delaying the medication’s delivery.

    In 2012, FDA issued its first Class I recall related to the device, warning users not to use the device with unapproved drugs. And then a year later, the agency released three separate Class I recalls related to the device. Bloomberg reported that the pump had been linked to 14 deaths.

    FDA apparently wasn’t pleased with how the company dealt with the situation and in April of this year, it filed a consent decree against the company for “repeatedly failing to correct violations” related to the device.

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  • 2. A Class I Infusion Pump Recall Medtronic Inherited from Covidien

    Medtronic may have had its own infusion pump troubles, but it also inherited some Covidien. Earlier this year, FDA issued a Class I recall of the Trellis 6 and Trellis 8 peripheral infusion systems, which were made by Covidien before its $48 billion merger with Medtronic.  last month—have two balloons that are inflated to isolate a clot in an arm, leg, hand, or foot. Medication is released between the balloons to shrink or dissolve the clot so it can be removed.

    FDA blamed a “manufacturing error” for the mislabeling of the ports. If the balloons are inflated in the incorrect order, “there is a potential for blood clots to dislodge and move into the lungs,” the agency said in a statement. “Depending upon the size of these clots, there is the possibility of serious patient injury or death.”

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  • 3. CareFusion’s Alaris Pump Hit with 6 Serious Recalls

    CareFusion, which became part of BD early this year, has had its own share of infusion pump issues. Out of the 11 Class I–level recalls it experienced from 2012 through 2014, six involved recalls for Alaris-model infusion pumps.

    Last year, it turned out that the Alaris Pump Module (Model 8100) had software failure issues. In 2012, the Model 8100 had recalls involving potential motor stalls at  high infusion rates, as well as the pump module door keypad overlay separating from the keypad assembly.

    The CareFusion Alaris PC unit, Model 8015 had its own serious issues in 2012 and 2013: models shipped with lower-voltage electronics than they should have had, a software error when certain modules were attached, and a component on the infusion pump's PC unit power supply board causing an error code.

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  • 4. FDA Orders Baxter to Destroy Colleague Infusion Pumps

    In 2010, FDA ordered Baxter Healthcare to not only recall but also destroy its line of Colleague Single- and Triple Channel infusion pumps. The agency made this determination based on its judgement that the company had not done a sufficient job addressing quality problems related to the pumps.

    For its Colleague branded devices, the company was compelled to offer its customer either a refund or replacement devices.

    Last year, Baxter recalled another one of its Sigma Spectrum infusion pumps over a serious system error, according to the FDA.

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  • 5. Hospira’s Problem-Beset Plum Line

    Hospira’s Plum line of infusion pumps have seen 17 quality problems from 2011–2014. Four of those triggered recalls while the majority of others resulted in field corrections. The problems with the pumps include everything from inaudible alarms to battery problems to a broken door roller assembly.

    It is interesting that the company describes is Plum A+ infusion system as “a proven performer”—with more than 325,000 of the pumps installed worldwide—when 14 of the aforementioned quality problems were tied to the device.

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  • 6. Hospira Pump Vulnerable to Hacking

    Hospira’s Plum line isn’t the only infusion pump from the company with quality concerns. The FDA this year warned of hacking vulnerabilities related to Hospira’s widely used LifeCare PCA3 and PCA5 infusion pump systems, basing its assessment on an independent researcher who determined that the pump could be hacked.

    Health providers are able to reprogram the LifeCare pumps over a healthcare facility’s Ethernet or a wireless network.  But there are apparently software vulnerabilities that could allow hackers access.

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  • 7. Hospira’s GemStar: How Pump with 5 Serious Failures

    We don’t mean to pick on Hospira, but the company has seen its infusion pumps linked to more Class I recalls than those of any other manufacturer since 2012.

    Out of the nine Class I–level recalls that Hospira has had since the start of 2012, five have involved the GemStar Infusion System.

    The FDA in late April 2013 labeled a Hospira recall of the GemStar pumps as Class I because of the seriousness of a low voltage battery issue.

    Within days, on May 1, 2013, there was a second Class I over leaking GemStar batteries.

    Then in November 2013, there was a third Class I over a completely different issue: drifting proximal and distal pressure sensor calibration for pumps that were either manufactured or had a pressure sensor replaced since January 1, 2009.

    On May 9, 2014, the fourth Class I recall was announced by FDA, this time involving potential malfunctions with the GemStar docking station—a separately sold accessory to the pump that provides an alternate power source.

    Finally, in November 2014 there was news that the power supply may not properly deliver electricity. Hospira noted at the time that all 13,002 units distributed worldwide, including 5,687 in the United States, might fail, according the FDA.

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  • 8. A J&J Pump That Doses Incorrectly

    J&J’s Codman and Shurtleff Inc. designed its implantable MedStream Programmable Infusion Pump to deliver the drug Baclofen to treat muscle disorders. In Europe, Middle East, and Africa, the device is also used to deliver morphine as well as Baclofen.

    Problems began to crop up in the devices made from March 2009 to September 2012, which were found to incorrectly dose drug volumes to patients. FDA gave the recall Class I status on October 23, 2013, explaining in its notice: "Air in the pump reservoir may release a higher dosage of drug than expected, leading to drug overdose. This product may cause serious adverse health consequences, including low blood pressure (hypotension), an abnormally slow heart rate (bradycardia), loss of consciousness, and/or death."

    Further problems led to a separate Class I recall related to a malfunction of the fill level sensor, intended to measure the contents of the pump drug reservoir.

8 of the Biggest Infusion Pump Fails

Their errors may have not elicited the same horror from the public as metal-on-metal hip implants or vaginal meshes. But infusion pumps have been one of the most recall-plagued medical devices in the past decade. From 2005 through 2009 alone, FDA received roughly 56,000 reports of adverse events linked to infusion pumps. In that time frame, 87 infusion pumps were recalled in the United States for safety reasons. The debacle led to more rigorous usability testing requirements for medical devices writ large. Yet Infusion pumps continue to be implicated in a substantial proportion of Class I recalls.  

Here’s a recap of some of the most prevalent infusion pump recalls in recent memory:

Continue >>

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