BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2950979 · Received February 8, 2013

    Report

    Report Number
    1416980-2013-03363
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    February 23, 2012
    Report Date
    January 14, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    FPA
    PMA / PMN Number
    K860272
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR RELEVANT ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. THE REPORTED CONDITION OF A LEAK WAS NOT CONFIRMED. VISUAL EXAMINATION OF THE SAMPLE SHOWED NO SIGNS OF PHYSICAL ABNORMALITY. THE DEVICE WAS ATTACHED TO A CLEARLINK AND INTERLINK SITE AND FUNCTIONAL TESTING SHOWED NO SIGNS OF LEAKAGE ON ANY PART OF THE DEVICE. THE DEVICE WAS ALSO PRESSURE TESTED UNDERWATER AND NO SIGNS OF LEAKAGE WERE OBSERVED. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO A BAXTER REPRESENTATIVE A CONDITION OF ONE INTERLINK Y-TYPE SOLUTION SET THAT WAS ALLEGED WITH A LEAK FROM THE LUER WHILE CONNECTED TO A NON BAXTER CATHETER. THIS CONDITION WAS REPORTED TO HAVE OCCURRED DURING INFUSION OF STEM CELLS ON AN UNKNOWN PATIENT. PATIENT WAS BEING REINFUSED WITH AUTOLOGOUS STEM CELLS USING A HUB-TO-HUB METHOD (DIRECT LUER CONNECTION AS OPPOSED TO SPLIT-SEPTUM CAP AND BLUNT CANNULA). THE INFUSION NURSE NOTED THAT THERE WAS LEAKING BETWEEN THE TUBING SET AND THE HUB OF THE PATIENT CATHETER. THE INFUSION WAS STOPPED THEN RESTARTED WITH A NEW TUBING SET FROM THE SAME BOX WITH NO FURTHER PROBLEM. THE INCIDENT WAS CAUGHT IMMEDIATELY AND TOTAL LOSS OF PRODUCT WAS 1-2ML. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THIS EVENT. THE SAMPLE IS AVAILABLE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54765 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - CLEVELAND GR291922

    Patients

    Seq Age Sex Outcome Treatment
    1 AUTOLOGOUS STEM CELLS| EDWARDS MULTIMED CATHETER