Terumo Sarns Modular Perfusion System 8000 Recalled for Monitor Malfunctions
Terumo CVS is recalling 26 Sarns Modular Perfusion System 8000 units due to reported malfunctions in arterial and cardioplegia monitors, including power issues and inaccurate pressure alarms.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects in critical medical devices, are rated as Severe (4). The malfunction of safety monitors in a life-support system poses a significant risk.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 26 units of the Sarns Modular Perfusion System 8000, base 4 pump, with 100V safety monitor included. The affected units have catalog number 16409 and serial numbers ranging from 1001 to 1026.
The recall is due to multiple reports received since 2007 regarding malfunctions of the arterial and cardioplegia monitors. These malfunctions are categorized as monitor power failures, the inability to measure pressure, and inaccurate or false pressure alarms. The device is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.
The affected units were distributed worldwide, including nationwide in the United States and in various countries such as Argentina, Australia, Germany, Japan, and Mexico. Healthcare facilities and users should contact Terumo CVS for instructions on how to proceed with the recall.
The recalled product
- Product
- Perfusion System 8000, base 4 pump, 100V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when…
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 26
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- catalog number: 16409 serial numbers: 1001-1026
Distribution
Part of a larger recall action
This product is one of 6 recalled by Terumo Cardiovascular Systems Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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