High FDA (Devices)·Z-0129-2013·Announced 2012-10-31

Terumo Recalls Sarns Modular Perfusion System 8000 Due to Power Malfunctions

Terumo Cardiovascular Systems is recalling 312 Sarns Modular Perfusion System 8000 units worldwide due to reported malfunctions in power distribution and battery back-up systems.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medical device used during critical surgical procedures (cardiopulmonary bypass). Although the source notes that most malfunctions occurred during setup or maintenance rather than active bypass, the potential for harm during a life-sustaining procedure places this in the 'High' category (risk-of-harm products where injury has not yet been reported).

Plain-English summary

Terumo Cardiovascular Systems Corporation is recalling 312 units of the Sarns Modular Perfusion System 8000, base 5 pump, with 220V/240V safety monitor included. The affected devices are identified by catalog number 16406 and specific serial numbers ranging from 1001 to 1823. The recall covers units distributed worldwide, including the United States and numerous international locations.

The recall was initiated after the company received multiple reports since 2007 regarding various malfunctions of the power distribution and battery back-up systems. According to the source text, very few of these reports occurred during cardiopulmonary bypass procedures; the majority of the malfunctions occurred during set-up or were reported during routine preventative maintenance.

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. The device is intended for use by qualified medical professionals experienced in operating similar equipment. Users should contact the recalling firm for further instructions regarding the affected units.

The recalled product

Product: Perfusion System 8000, base 5 pump, 220V/240V 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, wh
Manufacturer: Terumo Cardiovascular Systems Corporation
Category: Medical Device — Cardiovascular / Perfusion
Hazard: power-malfunction
battery-backup-failure
Affected units: 312

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 (8)

Catalog number: 16406 and serial numbers: 1001-1004
1007-1055
1057-1310
1648
1649
1657
1822
and 1823.

Distribution

Distributed in 42 states:

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.

See all 6 products in this recall →

Same manufacturer · Terumo Cardiovascular Systems Corporation

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Same hazard · power malfunction