BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2232032 · Received September 1, 2011

    Report

    Report Number
    6000001-2011-22258
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 11, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K982102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE CONTAINING APPROXIMATELY 20 ML OF SOLUTION IN THE RESERVOIR. VISUAL EXAMINATION OF THE UNIT CONFIRMED THE REPORTED CONDITION OF A LEAK, OBSERVED AT THE CONNECTION OF THE BLUE WINGED LUER CAP WHICH WAS NOT SECURELY TIGHTENED. AFTER THE CAP WAS SECURELY TIGHTENED, THE LEAKAGE COMPLETELY STOPPED. FUNCTIONAL TESTING OF THE DEVICE REVEALED NO SIGNS OF LEAK AFTER A 24-HOUR LEAK-MONITORING PERIOD. THE ROOT CAUSE WAS DETERMINED TO BE AN UNTIGHTENED WINGED LUER CAP. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. THE BATCH REVIEW REVEALED THAT ALL OF THE ACCEPTANCE CRITERIA WERE MET TO RELEASE THE LOT. THERE WERE NO NON-CONFORMANCES, FAILURES, REWORK, OR DEVIATIONS RELATED TO THE LOT. THERE WERE NO CHANGES TO SPECIFICATIONS, TEST METHODS, PROCESS, EQUIPMENT, OR RAW MATERIALS THAT COULD BE ASSOCIATED WITH THE REPORTED CONDITION.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT AN INFUSOR LEAKED AFTER FILLING. THE DEVICE WAS FILLED WITH AN ANTIBIOTIC SOLUTION. 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. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 11C027

    Patients

    Seq Age Sex Outcome Treatment
    1