BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSO.R.

    MDR report key: 2791910 · Received October 15, 2012

    Report

    Report Number
    1416980-2012-02484
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 4, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K883577
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE CONDITION WAS CONFIRMED BY SERVICE. "THIS COMPLAINT IS AN ANCILLARY SERVICE EVENT." "THE CAUSE WAS IDENTIFIED TO BE AN INCOMPLETE DEVICE RETURNED." THE DEVICE WAS RETURNED UNREPAIRED DUE TO CUSTOMER REFUSAL OF THE COST OF REPAIR ESTIMATE. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SENT.

    Description of Event or Problem · 1

    DURING PRODUCT EVALUATION BY A BAXTER SERVICE TECHNICIAN, AN INFUSO.R. PUMP WAS FOUND TO BE MISSING A REAR CASE SCREW. "THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. THIS WAS NOT REPORTED BY THE CUSTOMER." "THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATION WITH THIS EVENT." 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