BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 2101525 · Received May 25, 2011

    Report

    Report Number
    6000001-2011-04607
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 29, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: 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.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: BAXTER RECEIVED ONE DEVICE FOR EVALUATION. THE DEVICE WAS RECEIVED WITH THE BLUE WINGED LUER CAP UNTIGHTENED. ONCE THE CAP WAS TIGHTNENED, NO LEAK WAS DETECTED. THE REPORTED CONDITION WAS NOT CONFIRMED AND A ROOT CAUSE COULD NOT BE IDENTIFIED. A BATCH REVIEW WAS CONDUCTED WHICH FOUND NO NONCONFORMANCES.

    Description of Event or Problem · 1

    BAXTER CANADA RECEIVED A REPORT THAT ONE (1) CE INTERMATE UNIT LEAKED FROM THE WINGED LUER CAP. THE DROPLETS WERE NOTED IN THE OVERPOUCH AND THE LABELS WERE WET. THE WINGED LUER CAP COULD STILL BE TIGHTENED WITH A VERY SLIGHT TURN; THE FILL PORT CAP WAS TIGHT. THE PROBLEM WAS NOTED PRIOR TO PRODUCT USE AND THERE WAS NO PATIENT INVOLVEMENT. SAMPLE IS AVAILABLE FOR EVALUATION. ON (B)(4) 2011, BAXTER RECEIVED FOUR (4) DEVICES FOR EVALUATION INSTEAD OF THE ORIGINALLY REPORTED ONE (1) . THIS COMPLAINT WILL ADDRESS DEVICE 4 OF 4 FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 10M063

    Patients

    Seq Age Sex Outcome Treatment
    1