BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2082412 · Received May 9, 2011

    Report

    Report Number
    6000001-2011-03817
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 22, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K041738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: LEAK CONDITION NOT CONFIRMED. VISUAL EXAMINATION OF THE DISTAL LUER SHOWED NO SIGNS OF PHYSICAL ABNORMALITY. A LEAK TEST WAS SUBSEQUENTLY PERFORMED BY FILLING THE DEVICE WITH GREEN WATER AND MONITORED FOR 24 HOURS. AFTER 24 HOURS OF MONITORING PERIOD, NO SIGNS OF LEAK WERE NOTED AT THE DISTAL LUER OR ANYWHERE ON THE ENTIRE DEVICE. A BATCH REVIEW HAS BEEN CONDUCTED WHICH REVEALED PRODUCT MET ALL ACCEPTANCE CRITERIA FOR RELEASE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: 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.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT ONE (1) CE INFUSOR LV10 DEVICE LEAKED DURING PATIENT USE AFTER APPROXIMATELY 4 HOURS OF USE AT THE LEVEL OF THE DISTAL LUER. THE DEVICE WAS FILLED WITH CHEMOTHERAPY MEDICATION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. 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 11B054

    Patients

    Seq Age Sex Outcome Treatment
    1 CHEMOTHERAPY MEDICATION