BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 3242473 · Received July 23, 2013

    Report

    Report Number
    1416980-2013-19421
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED UNIT CONFIRMED THE REPORTED ISSUE. A CIRCULAR CRACK LOCATED AT THE TOP AREA OF THE LAVENDER COILED CAP WAS OBSERVED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE CAUSE WAS DETERMINED TO BE A MANUFACTURING ISSUE. IN ORDER TO ADDRESS THIS ISSUE, AWARENESS TRAINING WAS GIVEN TO THE APPROPRIATE PERSONNEL IN THE MANUFACTURING FACILITY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE FILLING OF A FOLFUSOR SV2.5 WITH NACL, THE COIL CAP WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344089 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 12N002

    Patients

    Seq Age Sex Outcome Treatment
    1