BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2122689 · Received June 14, 2011

    Report

    Report Number
    6000001-2011-07629
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 30, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K982102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER FOR EVALUATION; HOWEVER, THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION AND/OR SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED COMPLAINT INCIDENT FOR "NO FLOW/NON DELIVERY" AFTER FILLING WAS NOT CONFIRMED. FLOW WAS READILY OBSERVED AT THE INFUSOR'S LUER AND ALSO AT THE NEEDLE WHEN CONNECTED TO THE LUER. FLOW CONTINUED WITHOUT STOPPING UNTIL THE SOLUTION WAS EMPTIED FROM THE RESERVOIR. THE DEVICE PERFORMED AS EXPECTED. A BATCH REVIEW WAS CONDUCTED WHICH FOUND NO NONCONFORMANCES. 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.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT FOUR (4) HALF DAY INFUSOR, 5ML/HR 12PK DEVICES WOULD NOT FLOW DURING PATIENT USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. ONE SAMPLE IS AVAILABLE. THE DEVICE WAS FILLED WITH DESFERINE AND STERILE WATER. THIS REPORT WILL REFERENCE THE SAMPLE AVAILABLE. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10H072

    Patients

    Seq Age Sex Outcome Treatment
    1 DESFERINE, STERILE WATER