Terumo Advanced Perfusion System 1 Base, 220/240V, Catalog 801764, 6 " Roller Pump Occlusion: Reference AA-2011-015 C. i

FDA device recall Z-1321-2012 · posted 2012-03-27 · Terminated

Recall details

Recalling firm

Terumo Cardiovascular Systems Corporation

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.

Action taken

"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

Status

Terminated

Product code

DTQ

Quantity affected

648 units

Distribution

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,

Date initiated

2012-03-16

Date posted

2012-03-27

Date terminated

2013-05-02

Location

Ann Arbor, MI

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