BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 2910990 · Received January 11, 2013

    Report

    Report Number
    1416980-2013-00891
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN RECEIVED BY BAXTER FOR EVALUATION. ONCE THE EVALUATION IS COMPLETED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE WAS RECEIVED AND THE PROBLEM WAS CONFIRMED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF EVALUATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: A VISUAL INSPECTION OF THE SAMPLE FOUND THAT THE TUBING HAD SEPARATED FROM THE STRESS-MEMBER, WHICH HAD RESULTED IN A LEAK. THE REPORTED CONDITION WAS DETERMINED TO BE CAUSED BY NO SOLVENT ON THE TUBING, WHICH WAS A RESULT OF OPERATOR OVERSIGHT. AS A CORRECTIVE ACTION, RETRAINING WAS PERFORMED FOR THE ASSEMBLY PROCESS. ADDITIONAL INFORMATION: 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.

    Description of Event or Problem · 1

    A CUSTOMER HAD CONTACTED BAXTER CORPORATE SURVEILLANCE REGARDING AN INTERMATE, WHICH HAD LEAKED BEFORE USE. THE UNIT STARTED TO SLOWLY LEAK SOLUTION FROM THE PROXIMAL END OF THE INTERMATE TUBING. REPORTEDLY WHEN THE TUBING WAS RELEASED FROM THE INTERMATE GROOVE, THE UNCOILED TUBING EASILY SLID OUT OF THE ATTACHMENT PORT, IN THE TOP OF HOUSING. THE LEAK WAS NOTICED AFTER STERILIZATION PROCESS, WHEN THE MEDICINE WAS ALREADY IN THE INTERMATE. THERE WAS NO PATIENT INVOLVEMENT, INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18973 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 12G014

    Patients

    Seq Age Sex Outcome Treatment
    1