BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE LV 50, 24 PACK, 50126

    MDR report key: 1911168 · Received November 30, 2010

    Report

    Report Number
    6000001-2010-05335
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 4, 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' COULD NOT BE CONFIRMED. 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. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. 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 AT THE LOCATION OF THE BLUE WINGED CAP. THE DEVICE WAS FILLED WITH 90MG OF PAMIDRONATE IN 250ML 0.9% SODIUM CHLORIDE. THE PRODUCT WAS NOT ADMINISTERED TO THE PATIENTS. THE LEAK WAS NOTED PRIOR TO PRODUCT USE AND THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. THIS IS REPORT 12 OF 17 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