BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INFUSOR LV 2, 12 PACK

    MDR report key: 2021701 · Received March 17, 2011

    Report

    Report Number
    6000001-2011-01929
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K041738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: 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).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT THE RESERVOIR OF ONE (1) CE INFUSOR LV 2 HAD RUPTURED AND LEAKED ONTO THE HOSPITAL BED. IT WAS BEING INFUSED WITH 192ML OF 5-FLUOROURACIL AND NORMAL SALINE OVER 96 HOURS. IT IS REPORTED THAT TOWARDS THE END OF THE FOURTH DAY THE RUPTURE OCCURRED LEAVING APPROX 40-50ML OF SOLUTION IN THE DEVICE. THERE IS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INFUSOR LV 2, 12 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10J047

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR NORMAL SALINE| 5-FLUOROURACIL