BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLFUSOR SV 0.5 ML/H

    MDR report key: 1932225 · Received December 17, 2010

    Report

    Report Number
    6000001-2010-05887
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 21, 2010
    Report Date
    November 22, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED TO BAXTER FOR EVALUATION. THEREFORE, THE REPORTED CONDITION OF "RESERVOIR RUPTURED" COULD NOT BE CONFIRMED. SHOULD THE SAMPLE AND/OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE WILL BE IDENTIFIED/ADDRESSED THROUGH THE CAPA INVESTIGATION, (B)(4). THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(6) THAT THE RESERVOIR OF ONE (1) FOLFUSOR SV 0.5 DEVICE HAD RUPTURED DURING PATIENT USE. ACCORDING TO THE REPORT, THE DEVICE WAS FILLED WITH 2600MG OF 5-FLUOROURACIL AND THERE WAS APPROXIMATELY 50% OF SOLUTION REMAINING AT TIME OF RUPTURE. IN ADDITION, THE SOLUTION LEAKED ONTO THE PATIENT'S BED AND INTO THE CARRY BAG; HOWEVER, THERE IS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. THE PATIENT WAS ADMITTED TO HOSPITAL SO THAT THE FOLFUSOR COULD BE DISPOSED OF SAFELY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOLFUSOR SV 0.5 ML/H PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10B062

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR 5-FLUOROURACIL