Sarns Modular Perfusion System 8000 Catalog number 149112 or 78-8067-4840-2 Temperature-Pressure Board, Arterial Monitor

FDA device recall Z-1453-2012 · posted 2012-04-23 · Terminated

Recall details

Recalling firm

Terumo Cardiovascular Systems Corporation

Reason for recall

Terumo received multiple reports of malfunctions of the Cardioplegia and arterial monitors for the Sarns Modular Perfusion System 8000. Upon review of complaint investigation, the malfunctions are caused by or could have been caused by soldering anomalies on the circuit board of the monitor. The compromised solder joints could cause intermittent or loss of display, or could cause monitor reset, po

Action taken

TERUMO sent an URGENT MEDICAL DEVICE RECALL- SAFETY ADVISORY to all consignees on March 21, 2012 via Federal Express. Terumo issued the safety advisory to remind users how to intervene if they experienced intermittent or complete loss of pressure display on the arterial monitor or cartiplegia monitor, or a related pump stop. Customers were asked to review the Medical Device Correction notice, assure that all users are aware of the notice, confirm receipt of the communication by faxing the attached Customer Response Form to 1-800-292-6551. For questions regarding this recall call 1-800-521-2818.

Root cause

Device Design

Status

Terminated

Product code

DTQ

Quantity affected

3,022

Distribution

Worldwide Distribution - USA including AK, AL , AR, AZ , CA, CO , CT, DC, DE , FL, GA, HI, IA , ID , IL, IN , KS, KY , LA, MA , MD, MI, MN , MO, MS , MT, NC , ND, NE, NH, NJ, NM , NY, OH , OR, PA , RI

Date initiated

2012-03-21

Date posted

2012-04-23

Date terminated

2013-07-11

Location

Ann Arbor, MI

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