BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 3112494 · Received May 14, 2013

    Report

    Report Number
    1416980-2013-12321
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 19, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: VISUAL INSPECTION OF THE DEVICE CONFIRMED THE REPORTED ISSUE. THE COILED CAP WAS FOUND TO BE SEPARATED FROM THE COVER. THE CAUSE OF THE SEPARATION WAS A WARPED/MALFORMED COVER DUE TO EXPOSURE TO VERY HIGH HEAT TEMPERATURE CONDITIONS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4): INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. A BATCH REVIEW WAS CONDUCTED AND REVEALED THAT ALL OF THE ACCEPTANCE CRITERIA WERE MET TO RELEASE THE LOT. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED OF AN INTERMATE DEVICE IN WHICH THE CAP POPPED OFF PRIOR TO ADMINISTRATION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212219 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 13B004

    Patients

    Seq Age Sex Outcome Treatment
    1