BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3081822 · Received April 29, 2013

    Report

    Report Number
    1416980-2013-10627
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 5, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K981792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY:BAXTER RECEIVED ONE UNUSED COMPANION SAMPLE FOR EVALUATION. THE CUSTOMER REPORTED CONDITION WAS NOT CONFIRMED. VISUAL EXAMINATION OF THE SAMPLE SHOWED NO SIGNS OF PHYSICAL DEFECT INCLUDING FILTER INTEGRITY. FUNCTIONAL TESTING WAS PERFORMED AND SHOWED NO SIGNS OF PARTICULATE MATTER OR FILTER DEGRADATION. NO ROOT CAUSE WAS IDENTIFIED, AS NO EVIDENCE OF PRODUCT MALFUNCTION WAS OBSERVED. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT.

    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 REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLEARLINK PACLITAXEL SETS FILTER WAS FOUND TO HAVE DEGRADED DURING INFUSION. A NON-BAXTER DRUG WAS DILUTED IN 250 CC'S OF NORMAL SALINE AND WAS BEING INFUSED AT A RATE OF APPROXIMATELY 280 CC'S/HOUR. AFTER THE 1-HOUR INFUSION THE SET WAS INSPECTED, THE FILTER APPEARED TO HAVE DEGRADED. THE CUSTOMER NOTED THAT ALL OF THE DEGRADED MATERIAL APPEARED TO REMAIN IN THE FILTER. THERE WAS PATIENT INVOLVEMENT; HOWEVER THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185294 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R12K09013

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR SIGMA SPECTRUM INFUSION PUMP| TAXOTERE, NORMAL SALINE