FDA Device

Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.

Hazard

The tube clamp mechanism on the roller pump may not open when the rotation knob is turned, making it difficult to remove and/or insert tubing.

What You Should Do

Remedy

The firm is visiting the consignees as complaints are received and making corrections. Corrections were made in August 2005 and April 2006 to date. Other units will be repaired if complaints are received and the firm issued a Device Correction Letter dated 6/6/07 notifying all users of the problem and appropriate action to take should it occur.

Products

Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.
Brand
Terumo Cardiovascular Systems Corp
UPC
Serial number range 0033 through 1308 may be affected by this problem. Serial numbers 1060 and 1148 have been corrected.

Units Affected

1982 total for both models