BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 2110869 · Received June 2, 2011

    Report

    Report Number
    6000001-2011-06957
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 10, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. VISUAL AND FUNCTIONAL TESTS WERE PERFORMED AND THE REPORTED CONDITION COULD NOT BE CONFIRMED. THE DEVICE PERFORMED AS EXPECTED. A BATCH REVIEW WAS CONDUCTED WHICH FOUND NO NONCONFORMANCES.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER FOR EVALUATION; HOWEVER, THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION AND/OR SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    BAXTER RECEIVED A REPORT THAT ONE (1) INTERMATE DEVICE DID NOT FLOW WHEN CONNECTED TO THE PATIENT. THE CUSTOMER REPORTED THE DEVICE WOULD NOT DISPENSE THE MEDICATION. THE INTERMATE WAS FILLED WITH SODIUM CHLORIDE AND VANCOMYCIN. THE PATIENT'S LINE WAS FLUSHING WITH SODIUM CHLORIDE FLUSHES. THE DEVICE WAS HOOKED UP TO THE PATIENT FOR SEVERAL HOURS AND WORKING FINE. WHEN THE DEVICE WAS UNHOOKED FROM PATIENT AND UNCLAMPED, THERE WAS NO FLOW. NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 11C042

    Patients

    Seq Age Sex Outcome Treatment
    1 VANCOMYCIN| SALINE