First it was leaky battery damage. Now it is pressure sensor calibration drift.
For the second time this year, the FDA has classified a Hospira recall of its GemStar Infusion System as Class I, which means there is potential for significant injury or death related to the device.
Two separate, serious faults in the same device raises questions over whether there were systemic issues behind the way Lake Forest, IL-based Hospira was guaranteeing manufacturing quality for device components—a growing challenge for many medical device manufacturers as supply networks become increasingly complex and outsourced.
Hospira, in fact, received a Form 483 letter from FDA earlier this year due to concerns over its manufacturing practices.
Issues with the GemStar 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 latest Class I designation, announced last week, involves 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.
The FDA explains:
“A pump with this issue may, instead of reporting an error, not detect occlusions or issue false occlusion alarms, which will stop the infusion and invoke visual and audible warnings to the user. This issue may also result in the pump shutting down. Potential risks include a delay/interruption in therapy or over-infusion, which have a worst case potential to result in significant injury or death.”
Earlier this year, the Class I-worthy fault was battery malfunctioning tied to GemStar pumps made or distributed from February 1999 through April 2013.
When the battery level dropped below a certain level, the screen displayed an error—causing the device to stop functioning.
Both Class I-level recalls involved the same GemStar Infusion System models: 13000, 13100, 13150, 13086, 13087, and 13088.
In November of last year, the FDA banned the importation of Hospira’s Symbiq infusion pumps.
