BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 2101014 · Received May 24, 2011

    Report

    Report Number
    6000001-2011-04475
    Event Type
    Malfunction
    Date Received
    May 24, 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: LEAK CONDITION CONFIRMED. VISUAL EXAMINATION REVEALED BROKEN TUBING AT THE LUER POST. THE ROOT CAUSE OF THIS CONDITION COULD NOT BE DETERMINED. A BATCH REVIEW HAS BEEN CONDUCTED WHICH REVEALED THE PRODUCT MET ALL ACCEPTANCE CRITERIA FOR RELEASE.

    Description of Event or Problem · 1

    BAXTER RECEIVED A REPORT THAT ONE INTERMATE UNIT LEAKED FROM THE WINGED LUER CAP. 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. NO PATIENT INJURY OR MEDICAL INTERVENTION. FOUR DEVICES (4) WERE SENT IN INSTEAD OF THE INITIAL ONE (1) REPORTED. THIS COMPLAINT WILL ADDRESS DEVICE 2 OF 4 FROM THE 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