BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2231449 · Received September 1, 2011

    Report

    Report Number
    6000001-2011-22063
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 17, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    BRZ
    PMA / PMN Number
    K993120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT BEEN RECEIVED FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE OR THE SAMPLE IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION OF AN ADMINISTRATION SET IN WHICH A LEAK WAS OBSERVED WAS NOT CONFIRMED BECAUSE THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. THE ASSIGNABLE ROOT CAUSE IS UNKNOWN AND NO CORRECTIVE ACTION WAS TAKEN. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED TO BAXTER US A Y-TYPE BLOOD/SOLUTION SET STDBLOOD FILTER THAT WAS BEING USED FOR STEM CELL TRANSPLANT INFUSION (LOT NUMBER UNKNOWN). THE REPORTER STATED THE TUBING WAS INSERTED INTO A BAG AND THE INFUSION BEGAN; A FEW MINUTES AFTER STARTING, A SMALL AMOUNT WAS FOUND LEAKING ON THE FLOOR. ON OBSERVATION OF THE TUBING, THEY NOTED A SMALL PUNCTURE HOLE A SHORT DISTANCE FROM THE LUER LOCK PORT. LUCKILY THEY COULD CHANGE THE TUBING SO THE STEM CELLS COULD BE INFUSED." THERE WAS NO REPORTED PATIENT INJURY OR MEDICAL INTERVENTION. THERE IS A SAMPLE AVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, BLOOD TRANSFUSION BRZ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1