BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE LV 50, 24 PACK, 50126

    MDR report key: 1873138 · Received October 18, 2010

    Report

    Report Number
    6000001-2010-04165
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 23, 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 INITIAL MEDWATCH REPORT WAS SUBMITTED STATING THE SAMPLE WAS DISCARDED BY THE CUSTOMER; HOWEVER, THE SAMPLE WAS RETURNED TO BAXTER FOR EVALUATION. DEVICE EVALUATION: ONE SAMPLE WAS RECEIVED BY BAXTER FOR EVALUATION. THE REPORTED CONDITION OF "LEAK" COULD NOT BE CONFIRMED. NO SIGNS OR EVIDENCE OF A LEAK WERE FOUND AT THE AREA OF THE BLUE WINGED LUER CAP OR ANYWHERE ON THE ENTIRE DEVICE. A LEAK TEST WAS ALSO CONDUCTED; HOWEVER, NO EVIDENCE OF LEAK WAS FOUND. THE SAMPLE PERFORMED AS EXPECTED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A BATCH REVIEW HAS BEEN CONDUCTED WHICH REVEALED PRODUCT MET ALL ACCEPTANCE CRITERIA FOR RELEASE.

    Additional Manufacturer Narrative · 1

    (B)(4).ADDITIONAL NARRATIVE: PER THE CUSTOMER, THE DEVICE HAS BEEN DISCARDED; THEREFORE, THE REPORTED CONDITION OF "LEAKING AT THE LUER LOCK LOCATION" COULD NOT BE CONFIRMED. 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 AT THE LUER LOCK LOCATION BEFORE USE. THE DEVICE WAS FILLED WITH PAMIDRONATE (90MG IN 250ML SODIUM CHLORIDE 0.9%). THE BLUE WINGED LUER CAP WAS SECURELY FASTENED AFTER FILLING; HOWEVER, WHEN THE DEVICE WAS BEING LABELED, THE BLUE WINGED CAP WAS OBSERVED LOOSE. THERE WAS NO REPORTED PATIENT INJURY OR MEDICAL INTERVENTION. THREE (3) CE INTERMATE LV50 DEVICES, ALL LOT# 10B075, WERE REPORTED LEAKING THROUGH THE BLUE WINGED LUER CAP. THIS REPORT IS FOR DEVICE 3 OF 3.

    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