BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE LV 50, 24 PACK, 50126

    MDR report key: 1933557 · Received December 20, 2010

    Report

    Report Number
    6000001-2010-06057
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 25, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: ONE SAMPLE WAS RECEIVED BY BAXTER FOR EVALUATION CONTAINING FLUID IN THE RESERVOIR. THE REPORTED CONDITION OF "LEAK" WAS CONFIRMED. UPON RECEIPT, A SMALL AMOUNT OF FLUID WAS ALSO NOTED IN THE BAG THAT ENCLOSED THE SAMPLES WHICH SUGGESTED SMALL LEAK MUST HAVE OCCURRED. THE SOURCE OF THE FLUID WAS VISUALLY OBSERVED AT THE CONNECTION OF THE BLUE WINGED CAP AND THE LUER BODY. A LEAK TEST WAS PERFORMED ON THE SAMPLE BY REFILLING IT WITH GREEN WATER. DURING THE LEAK TEST, THE SAMPLE WAS ALLOWED TO COMPLETELY PRIME AND THEN THE BLUE WINGED CAP WAS SECURELY FASTENED TO THE LUER BODY. THEREAFTER, THE SAMPLE WAS MONITORED FOR 24 HOURS. AFTER 24 HOURS OF MONITORING PERIOD, NO SIGNS OF LEAK WERE OBSERVED AT THE CONNECTION OF THE BLUE WINGED CAP AND THE LUER BODY, OR ANYWHERE ON THE SAMPLE. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT ONE (1) CE INTERMATE LV 50 DEVICE WAS OBSERVED LEAKING BEFORE USE. THE DEVICE WAS FILLED WITH 90MG OF PAMIDRONATE IN 250ML OF 0.9% SODIUM CHLORIDE AND THEN STORED IN THE REFRIGERATOR IN ITS ORIGINAL OVERPOUCH. SOLUTION WAS THEN OBSERVED COLLECTING INSIDE THE OVERPOUCH. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 3 WITH THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INTERMATE LV 50, 24 PACK, 50126 PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 10B075

    Patients

    Seq Age Sex Outcome Treatment
    1 SODIUM CHLORIDE| PAMIDRONATE