BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3122885 · Received May 21, 2013

    Report

    Report Number
    1416980-2013-13060
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    April 30, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K981792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS THE SAME PATIENT AS (B)(4). ACTUAL DATE OF THE EVENT IS UNKNOWN. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: SIXTY-FOUR (64) COMPANION SAMPLES WITH THE SAME LOT NUMBER AS THE REPORTED DEVICE WERE RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE SAMPLES REVEALED NO OBVIOUS DEFECTS. PERFORMANCE TESTING DID NOT FIND EVIDENCE OF THE REPORTED PROBLEM. EVALUATION OF THE COMPANION SAMPLES COULD NOT CONFIRM THE REPORTED PROBLEM. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLEARLINK PACLITAXEL SET HAD AN ERODED FILTER. THE SET WAS BEING USED WITH A NON-BAXTER CHEMOTHERAPY DRUG. THE LINES WERE NOT CONNECTED TO THE PATIENT AT THE TIME WHEN THE ERODED FILTER WAS FOUND. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223918 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R12K09013

    Patients

    Seq Age Sex Outcome Treatment
    1 TAXOTERE (CHEMOTHERAPY DRUG)