BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RE-MANUFACTURED IPUMP

    MDR report key: 1832431 · Received September 13, 2010

    Report

    Report Number
    6000001-2010-03116
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    July 1, 2010
    Report Date
    August 18, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K052973
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION OF OVERINFUSION WAS NOT CONFIRMED OR DUPLICATED. THEREFORE AN ASSIGNABLE CAUSE COULD NOT BE DETERMINED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED. COMPLAINT NO: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS CUSTOMER SERVICE REQUEST ON THIS PUMP. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. ?BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY BAXTER FOR EVALUATION. A FOLLOW UP MEDWATCH WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED TO BAXTER (B)(4) TECHNICAL SERVICES ONE IPUMP THAT IS OVERINFUSING. THE REPORTED CONDITION OCCURRED DURING BIO-MED TESTING. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THIS DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RE-MANUFACTURED IPUMP PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1