FDA Device

Delphi IVantage Volumetric Ambulatory Infusion Pump/System; Ref nos. 12864051FRE, Rev. 8 and 12864051DEL, Rev. 8.

Hazard

Potential for under-infusion without alarm; cassette rollers stop moving , but the pump shaft continues rotating without alarm.

What You Should Do

Remedy

Distributors were notified via letter dated 3/29/05 instructing them to retrieve and return the product.

Products

Delphi IVantage Volumetric Ambulatory Infusion Pump/System; Ref nos. 12864051FRE, Rev. 8 and 12864051DEL, Rev. 8.
Brand
Delphi Medical Systems
UPC
All serial numbers.

Units Affected

22 US and 147 international.