Medical device controller software update addresses critical failure
Cardiac Assist is issuing a software update for LifeSPARC Controller units that may experience critical failure causing the system to freeze, crash, or lose display functionality. Affected units are identified by specific serial numbers.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is classified as FDA Class I due to the critical role of the affected device in life-support extracorporeal circulation systems. FDA Class I designation requires a minimum severity score of 4 per the rubric. Although no deaths or injuries are reported in the source, the critical software failure in a blood pump controller poses potential for serious patient harm.
Plain-English summary
The LifeSPARC Controller, manufactured by Cardiac Assist, Inc., is a component of the LifeSPARC System used to pump blood through an extracorporeal circuit. Approximately 763 units have been distributed nationwide in the United States. The FDA has classified this as a Class I recall.
The issue involves critical software failures in certain controller units. During these failures, the software may freeze or crash, and the display screen stops showing data. This situation was initially addressed through a previous recall initiated on July 21, 2022. Cardiac Assist has now developed software update version 1.1.5 to resolve the issue.
Patients or healthcare providers in possession of affected units should implement the software update. The specific serial numbers of affected units are listed in the recall documentation. Affected units can be identified using the provided serial numbers and UDI/DI codes (00814112020562 for Model 5900-0000; 00814112020623 for Model 5900-0001).
The recalled product
- Product
- SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001. Component of LifeSPARC System, used to pump the blood through an extracorporeal circuit.
- Manufacturer
- Cardiac Assist, Inc
- Hazard
- software-failure
- display-failure
Distribution
Distributed nationwide across the United States.
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