BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE LV 50, 24 PACK, 50126

    MDR report key: 1890371 · Received November 3, 2010

    Report

    Report Number
    6000001-2010-04696
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 10, 2010
    Report Date
    October 10, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    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 BY BAXTER FOR EVALUATION CONTAINING APPROXIMATELY 200ML OF FLUID IN THE RESERVOIR. UPON SAMPLE RECEIPT, NO SIGNS OR EVIDENCE OF LEAK WERE DETECTED AT THE BLUE WINGED LUER CAP OR ANYWHERE ON THE ENTIRE DEVICE. A LEAK TEST WAS ALSO PERFORMED ON THE DEVICE; HOWEVER, NO EVIDENCE OF A LEAK WAS FOUND. 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.

    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 LEAKED FROM THE BLUE WINGED LUER CAP. THE DEVICE WAS FILLED WITH PAMIDRONATE. THE WAS OBSERVED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1