Perfusion System 8000, base 4 pump, 100V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated f

FDA device recall Z-0284-2013 · posted 2012-11-13 · 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 arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure alarms. If the malfunction of the arterial or cardio

Action taken

The firm, Terumo CVS, sent an "URGENT MEDICAL DEVICE RECALL" notice/Safety Advisory Alert dated September 24, 2012 and an addendum to the Operator's Manual to alert all affected Customers. The notice described the product, problem and actions to be taken. The customers were instructed to review this medical device recall notice; assure that all users are aware to this notice; place the addendum in the Operator's Manual just before page 4.1 and complete and return the attached Customer Response Form via Fax to: 1-734-741-6149 or email to:www.termuo-cvs.com. If you have any questions or concerns contact Terumo CVS Customer Service at 1-800-521-1818; Monday - Friday, 8 AM - 6 PM ET.

Root cause

Device Design

Status

Terminated

Product code

DTQ

Quantity affected

26

Distribution

Worldwide distribution: USA (nationwide) including states of: 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, NH, NJ, NM, NY, OH, OK, OR, PA

Date initiated

2012-09-25

Date posted

2012-11-13

Date terminated

2013-07-11

Location

Ann Arbor, MI

Related 510(k) clearances