Terumo Advanced Perfusion System 1 (APS1, System 1) 100/120V AC Product Usage: The Terumo Advanced Perfusion System 1 is

FDA device recall Z-1973-2013 · posted 2013-08-14 · Terminated

Recall details

Recalling firm

Terumo Cardiovascular Systems Corporation

Reason for recall

Terumo Cardiovascular Systems (TCVS) has become aware that an Advanced Perfusion System 1 (APS1) Centrifugal Pump 'Service Pump' message may occur due to user induced motor movement. In this instance, the APS1 will identify the movement (as it is designed) and display a Service Pump message error. The user might interpret this as a pump which requires service rather than a message displayed due to pump movement while not activated.

Action taken

Terumo Cardiovascular Systems (TCVS) notified their consignees of the Urgent Medical Device Recall letter dated 7/26/13 and was mailed 7/29/13. The notification provided reason for the device correction, affected product, how the device will be corrected, and the potential health hazard associated with a user's inaccurate interpretation of the service pump error message. Instructions for consignee responses to the recall notice communication may be faxed to 734-741-6149 or emailed to the address on the return form. If you have any questions or concerns, call Terumo Cardiovascular Systems (TCVS) Customer Service at 1-800-521-2818 M-F, 8am-6pm ET. Terumo Cardiovascular Systems (TCVS) will provide an addendum to the APS1 Manual to their consignees. The addendum will be placed at the beginning of Chapter 6, Centrifugal Control Unit.

Root cause

Device Design

Status

Terminated

Product code

DTQ

Quantity affected

1657 total

Distribution

Worlwide Distribution - US Nationwide: AL,AR,AZ, CA, CO, CT, DC, DE, FL,GA, HI, IA, ID, IL, IN, KY, LA, MA , MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT,

Date initiated

2013-07-26

Date posted

2013-08-14

Date terminated

2017-02-08

Location

Ann Arbor, MI

Related 510(k) clearances