BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2221648 · Received August 24, 2011

    Report

    Report Number
    6000001-2011-20541
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 27, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K982102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 FOR EVALUATION. 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 RESULTING FROM USER ERROR. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. ADDITIONAL INFORMATION: 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. A REVIEW OF THE PRODUCT LABELING WAS PERFORMED AND FOUND THE LABELING TO BE ADEQUATE.

    Description of Event or Problem · 1

    BAXTER SERVICE PERSONNEL REPORTED AN INFUSOR WHICH LEAKED AT THE CONNECTION OF THE BLUE WINGED LUER CAP. ONCE THE BLUE WINGED CAP WAS SECURELY FASTENED, THE LEAK COMPLETELY STOPPED. THIS CONDITION OCCURRED DURING EVALUATION. 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 11C009

    Patients

    Seq Age Sex Outcome Treatment
    1