BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INFUSOR LV 2, 12 PACK

    MDR report key: 1761287 · Received July 19, 2010

    Report

    Report Number
    6000001-2010-01757
    Event Type
    Malfunction
    Date Received
    July 19, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 6, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ACCORDING TO THE CUSTOMER, THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO BAXTER FOR EVALUATION. HOWEVER, THE CUSTOMER WAS ABLE TO PROVIDE PHOTOGRAPHS OF THE ACTUAL DEVICE. SHOULD AN EVALUATION BE POSSIBLE USING THESE PHOTOGRAPHS, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY:THE ACTUAL DEVICE WAS NOT AVAILABLE TO BE SENT TO BAXTER FOR EVALUATION. HOWEVER, THE CUSTOMER WAS ABLE TO PROVIDE DETAILED PHOTOGRAPHS OF THE ACTUAL DEVICE. USING THESE PHOTOGRAPHS, THE REPORTED CONDITION OF A RUPTURED RESERVOIR WAS CONFIRMED. THE ROOT CAUSE OF THIS ISSUE IS CURRENTLY BEING INVESTIGATED UNDER CAPA (B)(4).A BATCH REVIEW WAS PERFORMED FINDING THAT NO EXCEPTION/NON-CONFORMANCE REPORTS WERE DOCUMENTED FOR THIS LOT. ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT A COLLEAGUE INFUSION PUMP EXPERIENCED A BATTERY ISSUE. IT IS UNKNOWN WHEN OR AT WHAT PINT IN THE PROCESS THE REPORTED CONDITION OCCURRED. REVIEW OF THE DEVICE EVENT HISTORY DETERMINED THAT THIS CONDITION INTERRUPTED DELIVERY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION OF THIS DEVICE IS 6.13.92, WHICH IS CLASSIFIED AS REMEDIATED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT THE RESERVOIR OF AN INFUSOR LV 2 DEVICE RUPTURED DURING FILLING. THE DEVICE WAS BEING FILLED WITH 5-FLUOROURACIL AT THE TIME OF THE RUPTURE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY AS THIS EVENT DID NOT OCCUR DURING PATIENT USE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INFUSOR LV 2, 12 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 09N058

    Patients

    Seq Age Sex Outcome Treatment
    1