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Recall Observatory FDA recall evidence

Device product

Terumo¿ Advanced Perfusion System 1 (APS1, System 1) 100/120V AC Product Usage: The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns TM or similar equipment.

Z-1973-2013

July 26, 2013

Class II

Product summary

Firm
Terumo Cardiovascular Systems Corporation
Event
Event 65381
Status
Terminated
Classification
Class II
Quantity
1657 total
Official record key
device-enforcement:Z-1973-2013

Official wording

Reason: 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.

Code information: Catalog Number or Part Number: 801763 Description: 100/120V AC, Advanced Perfusion System 1

Distribution pattern: 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, WA, WI, WV and the countries of: AUSTRALIA,UNITED ARAB EMIRATES (UAE),Hong Kong, onesia,Singapore,Taiwan,Thailand, Philippines,CHILE, Malaysia,USA,South Korea,BELGIUM,Japan,Mexico,CANADA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.