BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSO.R.

    MDR report key: 2841024 · Received November 20, 2012

    Report

    Report Number
    1416980-2012-05686
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    September 30, 2012
    Report Date
    October 29, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K883577
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CUSTOMER REPORTED PROBLEM OF "DAMAGED SYRINGE HOLDER"? WAS NOT CONFIRMED IN SERVICE BECAUSE THE PUMP WAS NOT SENT IN FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FINDING THAT THERE WERE EXCEPTIONS, NONCONFORMITIES, AND/OR REWORKS THAT OCCURRED DURING THE MANUFACTURING OF THE COMPLAINT LOT OR SERIAL NUMBER. (B)(4). A SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE HAS NOT BEEN SERVICED PRIOR TO THIS EVENT.

    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.

    Description of Event or Problem · 1

    THE FACILITY REPORTED AN INFUSOR PUMP WITH "DAMAGED SYRINGE HOLDER". THE PROCESS STEP FOR THIS EVENT IS UNKNOWN. HOWEVER, IT IS KNOWN TO HAVE OCCURRED IN THE "SURGERY" 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