Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns Modular Perfusion System 8000 is indicat

FDA device recall Z-0129-2013 · posted 2012-10-24 · Terminated

Recall details

Recalling firm

Terumo Cardiovascular Systems Corporation

Reason for recall

Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the power distribution and battery back-up systems for the Sarns Modular Perfusion System 8000. Very few of the reports occurred during cardiopulmonary bypass; the majority of the malfunctions occurred during set-up or were reported during routine preventative maintenance. The malfunction

Action taken

TERUMO sent an URGENT MEDICAL DEVICE letter dated September 25, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed review the Medical Device Recall notice, assure that all users are aware of the notice and place the addendum in the Operator's Manual before page 1.13. Customers were also instructed to confirm receipt of the Urgent Medical Device letter by faxing, the attached Customer Response Form to 1-800-292-6551. For questions customers were instructed to call 1-800-521-2818.

Root cause

Labeling design

Status

Terminated

Product code

DTQ

Quantity affected

312 units

Distribution

Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, W

Date initiated

2012-09-25

Date posted

2012-10-24

Date terminated

2015-08-21

Location

Ann Arbor, MI

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