BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INFUSOR SV 2, 12 PACK

    MDR report key: 1862687 · Received October 8, 2010

    Report

    Report Number
    6000001-2010-03911
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 14, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K041738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE COULD NOT BE SENT TO BAXTER FOR EVALUATION DUE TO THE DEVICE BEING SOILED WITH A CHEMOTHERAPY DRUG (5-FLUOROURACIL). 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

    IT WAS REPORTED TO BAXTER (B)(4) THAT THE RESERVOIR OF AN INFUSOR SV 2 DEVICE RUPTURED DURING FILLING. THE DEVICE WAS BEING FILLED WITH A 96ML SOLUTION OF 5-FLUOROURACIL AND SODIUM CHLORIDE 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 SV 2, 12 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 09M076

    Patients

    Seq Age Sex Outcome Treatment
    1