BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 2192534 · Received August 5, 2011

    Report

    Report Number
    6000001-2011-16734
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 15, 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). THE DEVICE IS AVAILABLE FOR EVALUATION PER THE CUSTOMER; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). PER REVIEW OF THE BATCH RECORDS, NO NONCONFORMANCE REPORT WAS DOCUMENTED FOR THIS LOT. ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE LOT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE REPORTER INITIALLY REPORTED THAT THE SAMPLE IS AVAILABLE. HOWEVER, THE SAMPLE WAS NOT RETURNED TO BAXTER FOR EVALUATION. THEREFORE, THE REPORTED CONDITION COULD NOT BE CONFIRMED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. SHOULD THE DEVICE AND/OR ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT AN INTERMATE LEAKED FROM THE BLUE WINGED LUER LOCK CAP. THIS CONDITION OCCURRED BEFORE PATIENT USE. THIS CONDITION HAS THE POTENTIAL TO INTERRUPT THERAPY OR BREACH THE STERILE FLUID PATHWAY. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. THE SAMPLE IS AVAILABLE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 11B062

    Patients

    Seq Age Sex Outcome Treatment
    1