BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INFUSOR LV 5, 12 PACK

    MDR report key: 1760036 · Received July 16, 2010

    Report

    Report Number
    6000001-2010-01684
    Event Type
    Malfunction
    Date Received
    July 16, 2010
    Date of Event
    February 1, 2010
    Report Date
    February 4, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER DID NOT SEND THE DEVICE TO BAXTER FOR EVALUATION. THEREFORE, THE REPORTED CONDITION OF A RUPTURED RESERVOIR COULD NOT BE CONFIRMED. SHOULD THE SAMPLE AND/OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A RUPTURE ON A CE INFUSOR LV 5. THE RUPTURE WAS FOUND IN PREPARATION (FILLING). NO IMPACT ON THE PATIENT WAS REPORTED. NO SAMPLE AVAILABLE FOR EVALUATION; SAMPLE WAS DISCARDED DUE TO THEIR CYTOTOXIC CONTENT. THIS IS REPORT 46 OF 89 RECEIVED WITH THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INFUSOR LV 5, 12 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 09M010

    Patients

    Seq Age Sex Outcome Treatment
    1