BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPUMP

    MDR report key: 3150558 · Received June 6, 2013

    Report

    Report Number
    1416980-2013-14497
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 13, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K052973
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RECEIVED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. THE DEVICE PASSED ALL FUNCTIONAL TESTS. AN INTERNAL VISUAL INSPECTION IDENTIFIED FLUID INTRUSION BEHIND THE DIRECTION AND DRIVE MOTOR MODULE DAUGHTER BOARD, AS WELL AS ON THE MOTOR HARNESS CONNECTOR. A REVIEW OF THE ALARM LOG IDENTIFIED FIVE OCCURRENCES OF SYSTEM ALARM 30, WHICH IS A MOTOR CONTROL ERROR. THE REPORTED PROBLEM OF "NOT INFUSING" WAS CONFIRMED AS THE SYSTEM ALARM 30. THE CAUSE OF THE ALARM WAS DETERMINED TO BE FLUID INTRUSION. NO FURTHER TESTING HAS BEEN COMPLETED AT THIS TIME AND NO REPAIRS HAVE BEEN PERFORMED AS THE REFERENCED DEVICE HAS BEEN REMOVED FROM SERVICE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IPUMP DEVICE WAS "NOT INFUSING." THIS OCCURRED WHILE THE PUMP WAS BEING PROGRAMMED AND SET UP IN THE BIOMEDICAL SERVICE AREA. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249858 IPUMP PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1