BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSTREAM DIALYSIS CATHETER

    MDR report key: 1679223 · Received April 30, 2010

    Report

    Report Number
    1036710-2010-00013
    Event Type
    Malfunction
    Date Received
    April 30, 2010
    Date of Event
    April 9, 2010
    Report Date
    April 9, 2010
    Manufacturer
    ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES
    Product Code
    MSD
    PMA / PMN Number
    K071422
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EXAMINATION. THE DEVICE WAS RETURNED WITH THE ARTERIAL CLAMP CLOSED WITH LIQUID DRIED BETWEEN THE TUBES. WATER WAS PUSHED THROUGH THE ARTERIAL SIDE TO CONDUCT AN AIR LEAK TEST AND A LEAK WAS CONFIRMED. A BUBBLE TEST WAS CONDUCTED AND LEAKAGE WAS NOTED BETWEEN THE ADAPTOR AND THE LUER. A PRESSURE TEST WAS COMPLETED AND THE LEAK WAS CONFIRMED WITH MINIMAL PRESSURE. THE ADAPTOR WAS CUT OPEN TO INVESTIGATE FURTHER. THERE WERE NO HOLES OR CRACKS NOTED ON THE TUBING. THERE IS NO GAP BETWEEN THE ADAPTOR AND THE LUER. THE BONDING APPEARS NORMAL. DURING THE VISUAL INSPECTION, THERE WAS NO LIQUID PATH VISIBLE. THE ROOT CAUSE FOR THE LEAK COULD NOT BE DETERMINED WITH THE INVESTIGATION. EACH CATHETER IS LEAK TESTED DURING PRODUCTION TO DETECT ANY LEAKAGE DURING THE PRODUCTION OF THE DEVICE. PER THE RISK ANALYSIS, A LEAK ON THE ARTERIAL LUMEN IS LESS CRITICAL THEN A VENOUS LUMEN LEAK, AS THE MACHINE WILL ALARM AND THE DIALYSIS WOULD BE STOPPED DUE TO AIR IN THE DIALYSIS MACHINE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED: DIALYSIS WAS INITIATED ON THE PATIENT. THE ARTERIAL LINE OF THE DIALYSIS MACHINE CONTAINED AIR BUBBLES AS WELL AS BLOOD. DIALYSIS WAS STOPPED FOR PATIENT SAFETY. A SYRINGE WAS ATTACHED TO ARTERIAL CATHETER. WHILE THE ARTERIAL LINE WAS CLAMPED, THE PLUNGER OF THE SYRINGE WAS PULLED BACK AND AIR FILLED THE SYRINGE. A SALINE WAS THEN ATTACHED TO THE ARTERIAL LINE. WITH THE ARTERIAL LINE CLAMPED, THE SALINE SYRINGE WAS PUSHED AND SALINE EXITED THE CATHETER UNDER THE HUB AT THE VERY TOP OF THE CLEAR TUBING ON THE ARTERIAL SIDE. THE LINE WAS THEN CLAMPED TO ENSURE PATIENT SAFETY AND THE SURGEON NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOSTREAM DIALYSIS CATHETER HEMOSTREAM PEEL AWAY MSD ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES 32401528 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other