BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 4180373 · Received October 17, 2014

    Report

    Report Number
    1416980-2014-36209
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    September 23, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION ON THE UNIT (VIA THE NAKED EYE), NOTED A RUPTURED BLADDER. THE RUPTURED BLADDER WAS MICROSCOPICALLY INSPECTED AND REVEALED A MARKING LOCATED ON THE INTERIOR SURFACE OF THE BLADDER. THE ASSIGNABLE CAUSE OF THE RUPTURE COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. UPON COMPLETION OF THE INVESTIGATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLADDER OF A LARGE VOLUME FOLFUSOR RUPTURED. THIS OCCURRED DURING INFUSION WITH APPROXIMATELY 30 ML OF SOLUTION REMAINING. THE DEVICE WAS FILLED WITH 240 ML OF CEFTAZIDIME. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION OR ADVERSE EVENT ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663193 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14F017

    Patients

    Seq Age Sex Outcome Treatment
    1 CEFTAZIDINE