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Terminated

Terumo Advanced Perfusion System 1 Base, 220/240V, Catalog 801764, 6 " Roller Pump Occlusion: Reference AA-2011-015 C. indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.

FDA Recall Z-1321-2012 · Posted 2012-03-27

Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusTerminated
Product CodeDTQ
Date Initiated2012-03-16
Date Terminated2013-05-02
Product Quantity648 units

Reason for Recall

Terumo CVS has received reports of 27 instances in which the 6 inch Roller Pump jammed during cardioplegia delivery. There has been one report of the pump jamming during a case that concluded with an adverse patient outcome, although there was no indication that the pump jam contributed to the adverse patient outcome.

Firm Action

"URGENT MEDICAL DEVICE RECALL" letters were sent on 3/16/12 to all consignees detailing the correction as well as also adding an Addendum to the Operator's manual for the Terumo System 1 to incorporate additional information and warnings for use when operating a 6" roller pump with dual-sized tubing. For questions call 1-800-521-2818.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution--USA, including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, Puerto Rico and the countries of INDIA, CANADA, CHILE, HONG KONG, EGYPT, PAKISTAN, KUWAIT, SAUDI ARABIA, JORDAN, UNITED ARAB EMIRATES, SOUTH AFRICA, SOUTH KOREA, PHILIPPINES, JAPAN, PHILIPPINES, SINGAPORE, AUSTRALIA, MALAYSIA, TAIWAN, RUSSIA, TURKEY, BELGIUM, GERMANY, COLUMBIA, COSTA RICA, ARGENTINA, HONDURAS, COLUMBIA, DOMINICAN REPUBLIC, GUATEMALA, MEXICO, VIETNAM, and THAILAND.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K022947ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCHTerumo Cardiovascular Systems Corp. · 2003-03-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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