BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE LV 50, 24 PACK, 50126

    MDR report key: 1920362 · Received December 10, 2010

    Report

    Report Number
    6000001-2010-05717
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 16, 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). DEVICE EVALUATION: ONE SAMPLE WAS RECEIVED FOR EVALUATION BY BAXTER CONTAINING FLUID IN THE RESERVOIR. THE REPORTED CONDITION OF "LEAK" WAS CONFIRMED. VISUAL EXAMINATION REVEALED FLUID WAS NOTED IN THE BAG THAT ENCLOSED THE SAMPLE WHICH SUGGESTED LEAK MUST HAVE OCCURRED. THE SOURCE OF THE FLUID WAS VISUALLY OBSERVED AT THE CONNECTION OF THE BLUE WINGED CAP AND THE LUER BODY. THE WINGED CAP WAS VISUALLY NOTED TO BE ADEQUATELY FASTENED TO THE LUER BODY (THE CAP WAS NOT OVER-TIGHTENED OR UNDER-TIGHTENED). NO OTHER SOURCE OF LEAKAGE WAS FOUND. 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.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT ONE (1) CE INTERMATE LV50 DEVICE WAS OBSERVED LEAKING BEFORE USE. ACCORDING TO THE REPORT, THE DEVICE WAS FILLED WITH 250ML OF PAMIDRONATE (90MG IN 0.9% SODIUM CHLORIDE). THE CUSTOMER COULD NOT IDENTIFY THE LOCATION OF THE LEAK. THERE IS NO PATIENT INVOLVEMENT; THEREFORE, NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. THIS IS REPORT 1 OF 2 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 NORMAL SALINE| PAMIDRONATE