BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RE-MANUFACTURED IPUMP

    MDR report key: 1832444 · Received September 13, 2010

    Report

    Report Number
    6000001-2010-03119
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    June 24, 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 CONDITION OF OVERINFUSING WAS NOT CONFIRMED OR DUPLICATED THEREFORE, AN ASSIGNABLE CAUSE COULD NOT BE DETERMINED. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE HISTORY REVIEW WAS ALSO PERFORMED, FINDING THAT NO EXCEPTIONS WERE NOTED DURING THE MANUFACTURING OF THIS DEVICE.

    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 WHILE USING A FLOW METER. THE EXPECTED INFUSION RATE WAS 10.0 ML/HR AND THE MEASURED INFUSION RATE WAS 10.96 ML/HR. 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