BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR

    MDR report key: 3130549 · Received May 24, 2013

    Report

    Report Number
    1416980-2013-13411
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHARMACIST

    Narratives

    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 SAMPLE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FOLFUSOR SV 2.5 ML/H EXPERIENCED NO FLOW. THE PATIENT RETURNED TWO DAYS AFTER HER TREATMENT DAY TO HAVE THE PUMP DISCONNECTED AND LESS THAN 30% OF THE UNKNOWN DRUG APPEARED TO HAVE BEEN DELIVERED. THE PATIENT LINE WAS CHECKED AND THE PUMP WAS LEFT ON FOR AN ADDITIONAL FOUR DAYS, DURING WHICH NO MORE VOLUME WAS DELIVERED. IT WAS REPORTED THAT THE PATIENT WOULD NOT RECEIVE THE DRUG ANYMORE DURING THE AFFECTED TREATMENT CYCLE. NO REPORT OF PATIENT INJURY. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232083 FOLFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 12N002

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN DRUG