Hospira continues to struggle with serious problems related to its GemStar Infusion System and its accessories. The latest bad news came Wednesday, when the FDA designated a recall of the GemStar Power Supply, 3VDC, as Class I.
The GemStar Infusion System, as shown on a Hong Kong website.
It is the fifth time in nearly three years that FDA regulators thought an issue around a GemStar-related recall could result in serious injury or death, and it is the eighth time overall that Hospira has faced a Class I recall. (Only three other medical device companies—Johnson & Johnson, Medtronic, and General Electric—have had more Class I recalls than Hospira since the start of 2012.)
This time, it turns out the Power Supply, an accessory to the GemStar, may not properly deliver electricity. Hospira noted that all 13,002 units distributed worldwide, including 5,687 in the U.S., may fail, according the FDA.
Hospira has received reports of 20 incidents, including one report of smoke, and found that the GemStar Infusion Pump was operating on battery power while connected to the 3VDC power supply, the FDA said. There were no reports of injuries or death. A recalled list and lot numbers are included with the FDA announcement.
The GemStar provides a telling example of how a device can potentially fail in multiple ways. Issues are so serious because the infusion pump is administering delivery of IV fluids, food, and needed medications to patients laid up in both hospital and home settings.
The FDA in late April 2013 labeled a Hospira recall of the pumps as Class I because of the seriousness of a low voltage battery issue. When the battery level dropped below a certain level, the screen displayed an error—causing the device to stop functioning.
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Within days, on May 1, 2013, there was a second Class I over leaking GemStar batteries, which could potentially damage the device's innards and cause it to shut down.
Then in November 2013, there was a third Class I over a completely different issue: drifting issues around proximal and distal pressure sensor calibration for pumps that were either manufactured or had a pressure sensor replaced since Jan. 1, 2009.
Then just on May 9, the fourth Class I came out, this time involving potential malfunctions with the GemStar Docking Station—a separately sold accessory to the GemStar infusion pump that provides an alternate power source to the GemStar pump.
