BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INFUSOR LV10, 12 PACK

    MDR report key: 1880564 · Received October 22, 2010

    Report

    Report Number
    6000001-2010-04439
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 1, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K041738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER DISCARDED THE DEVICE. THEREFORE, THE REPORTED CONDITION OF A RUPTURED RESERVOIR COULD NOT BE CONFIRMED. THE ROOT CAUSE FOR RUPTURED RESERVOIRS IS CURRENTLY BEING INVESTIGATED UNDER CAPA# IDC-CAPA-(B)(4). A BATCH REVIEW WAS PERFORMED FINDING THAT NO EXCEPTION/NON-CONFORMANCE REPORTS WERE DOCUMENTED FOR THIS LOT. ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE LOT. SHOULD THE SAMPLE AND/OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT THE RESERVOIR OF AN INFUSOR LV 10 DEVICE RUPTURED BEFORE USE. THE DEVICE WAS FILLED WITH A 240ML SOLUTION OF BENZYLPENICILLIN, AT 30MG PER ML, AND NORMAL SALINE AT THE TIME OF THE RUPTURE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY AS THIS EVENT DID NOT OCCUR DURING PATIENT USE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INFUSOR LV10, 12 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10H018

    Patients

    Seq Age Sex Outcome Treatment
    1