BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2252068 · Received September 16, 2011

    Report

    Report Number
    6000001-2011-25230
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 23, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K041738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 AND THE FLOW RESTRICTOR. THE ROOT CAUSE WAS DETERMINED TO BE USER ERROR; THE CAP WAS NOT SECURELY TIGHTENED. AFTER THE CAP WAS SECURELY TIGHTENED, THE LEAKAGE COMPLETELY STOPPED. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. . 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. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A FOLLOW-UP REPORT WILL BE FILED IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE WAS NOT DETERMINED TO BE USER ERROR, AS PREVIOUSLY REPORTED. THE ROOT CAUSE OF THE LEAK WAS DETERMINED TO BE AN UNTIGHTENED WINGED LUER CAP.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT AN INFUSOR LEAKED AFTER FILLING. THE DEVICE WAS FILLED WITH A CYTOTOXIC DRUG. 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 11B015

    Patients

    Seq Age Sex Outcome Treatment
    1