BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSO.R.

    MDR report key: 2851496 · Received November 29, 2012

    Report

    Report Number
    1416980-2012-06155
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 6, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K883577
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE CUSTOMER REPORTED PROBLEM OF ?PUMP HAS A FEW THINGS BROKEN ON IT - WAS CONFIRMED DURING DEVICE EVALUATION. QUALITY ENGINEERING DETERMINED THE PROBLEM TO BE WITH THE SYRINGE HOLDER. THE CAUSE OF THE PROBLEM WAS PHYSICAL DAMAGE TO THE SYRINGE HOLDER. NO REPAIRS HAVE BEEN PERFORMED AS THE REFERENCED DEVICE HAS BEEN REMOVED FROM SERVICE. A DEVICE HISTORY REVIEW COULD NOT BE CONFIRMED AS THE LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 1

    THE FACILITY REPORTED AN INFUSOR PUMP IN WHICH THE "PUMP HAS A FEW THINGS BROKEN ON IT." THE PROCESS STEP FOR THIS EVENT IS UNKNOWN. HOWEVER, IT IS KNOWN TO HAVE OCCURRED IN THE "ANESTHESIA" DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT, PATIENT/USER INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSO.R. PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1