Battery, 220V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmon

FDA device recall Z-0050-2013 · posted 2012-10-11 · Terminated

Recall details

Recalling firm

Terumo Cardiovascular Systems Corporation

Reason for recall

Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2004 of various malfunctions of the battery backup system for the Sarns" Centrifugal System. The reports can be broadly categorized as follows: " Failure to charge " Failure to hold charge " Failure to operate In the most severe case, a battery malfunction could result in an unexpected loss of arterial flow. In

Action taken

TERUMO sent an Urgent Medical Device Recall letter dated June 25, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. On 09/25/2012 an URGENT MEDICAL DEVICE RECALL notification and addendum was sent to all consignees. TCS issued this notification as a Safety Advisory to alert all users of the Sarns centrifugal system of the potential for malfunction and remind them to review the appropriate sections of the Operators Manual for the Sarns Delphin Battery. Providing an addendum to the Operators Manual for the Sarns Delphin Battery with additional instruction on the use and charging of a discharged battery. Customers were instructed to review the Medical Device Recall notice; assure that all users are aware of the notice; place the addendum in the Operator's Manual; and confirm receipt of the communication by faxing or emailing the attached Customer Response Form. For questions customers were instructed to call 1-800-521-2818. For questions regarding this recall call 734-741-6173.

Root cause

Component design/selection

Status

Terminated

Product code

KFM

Quantity affected

289 units

Distribution

Worldwide distribution: USA including: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, UT, V

Date initiated

2012-09-25

Date posted

2012-10-11

Date terminated

2014-01-15

Location

Ann Arbor, MI

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