BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPUMP

    MDR report key: 3150549 · Received June 6, 2013

    Report

    Report Number
    1416980-2013-14493
    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 ANY ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY:THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION REVEALED DAMAGE TO THE PUMP MECHANISM WHICH CONFIRMED THE REPORTED CONDITION. THE CAUSE OF THE DAMAGE COULD NOT BE CONCLUSIVELY DETERMINED. 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
    249855 IPUMP PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1