BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INFUSOR SV 2, 12 PACK

    MDR report key: 1894522 · Received November 9, 2010

    Report

    Report Number
    6000001-2010-04791
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 18, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K041738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: ONE SAMPLE WAS RECEIVED BY BAXTER CONTAINING FLUID IN THE BLADDER. UPON RECEIPT, SOLUTION WAS ALSO NOTED IN THE BAG THAT CONTAINED THE SAMPLE WHICH SUGGESTED LEAKAGE MUST HAVE OCCURRED. THE SOURCE OF THE SOLUTION WAS VISUALLY OBSERVED AT THE CONNECTIVITY OF THE BLUE WINGED CAP AND THE LUER BODY. THE WINGED CAP WAS VISUALLY NOTED TO BE ADEQUATELY FASTENED ON THE LUER BODY. NO OTHER SOURCE OF LEAKAGE WAS FOUND. A BATCH REVIEW WAS CONDUCTED AND REVEALED THAT THE PRODUCT MET ALL ACCEPTANCE CRITERIA FOR RELEASE. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH CAPA (B)(4). THIS IS A SINGLE USE DEVICE AND WILL NOT BE REPAIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER THAT ONE (1) CE INFUSOR SV2 DEVICE WAS OBSERVED LEAKING IN THE STORAGE BAG AFTER FILLING. ACCORDING TO THE REPORT, THE DEVICE WAS FILLED WITH 94ML OF 5-FLUOROURACIL (UNKNOWN CONCENTRATION, NORMAL SALINE USED AS THE DILUENT) AND SAT OVERNIGHT. THE NEXT DAY, THE FACILITY DID A LAST CHECK OF THE SAMPLE PRIOR TO SENDING TO THE CANCER CENTER WHEN THEY NOTICED LEAKING IN THE BAG. THE PHARMACIST STATED THE BLUE WINGED CAP AND FILL PORT CAPS WERE SECURELY FASTENED AND THE LEAK WAS NOT OBSERVED WITHIN THE HOUSING. THE REPORTER STATED THE LOCATION OF THE LEAK IS UNKNOWN. THERE IS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INFUSOR SV 2, 12 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 09B008

    Patients

    Seq Age Sex Outcome Treatment
    1