BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRISMAFLEX

    MDR report key: 2700176 · Received August 13, 2012

    Report

    Report Number
    9616026-2012-00003
    Event Type
    Injury
    Date Received
    August 13, 2012
    Date of Event
    July 14, 2012
    Report Date
    July 14, 2012
    Manufacturer
    GAMBRO LUNDIA AB
    Product Code
    KDI
    PMA / PMN Number
    K072093
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRISMAFLEX CONTROL UNIT WITH SW 6.10 INVOLVED IN THIS EVENT DOES NOT HAVE 510(K) CLEARANCE, BUT IS SIMILAR TO PRISMAFLEX CONTROL UNIT SW 5.10 (501 (K) CLEARANCE K110823). AS INDICATED IN THE EVENT DESCRIPTION, PRIOR TO THE INCIDENT, THE PT'S CENTRAL VENOUS LINE IN THE RIGHT INTERNAL JUGULAR WAS REMOVED AND MOST LIKELY THE VEIN WAS NOT FULLY OCCLUDED WHICH ALLOWED AIR INGRESSION INTO THE RIGHT ATRIUM. AT THIS MOMENT WE CAN NEITHER CONFIRM NOR RULE OUT IF THE PRISMAFLEX CONTROL UNIT MALFUNCTIONED, CAUSED, OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    A PT WAS UNDERGOING CRRT ON A PRISMAFLEX MACHINE WHEN THE MACHINE GENERATED THE AIR IN BLOOD ALARM. ACCORDING TO THE NURSE, THE SET WAS FULL OF AIR FROM THE ACCESS LINE THROUGH THE FILTER AND INTO THE DE-AERATION CHAMBER. THE PT WAS IMMEDIATELY DISCONNECTED FROM THE SET WITHOUT RETURNING THE BLOOD AND 20 ML OF BLOOD WAS WITHDRAWN VIA SYRINGE FROM BOTH THE ACCESS AND RETURN LINE WITH APPROXIMATELY 5 ML OF AIR IN BOTH SYRINGES. THE PT WAS IMMEDIATELY PLACED ON HIS LEFT SIDE IN THE TRENDELENBURG POSITION. AS FURTHER BLOOD AND AIR WAS BEING REMOVED FROM THE LINE, THE PT HAD A CARDIOPULMONARY ARREST AND WAS SUCCESSFULLY RESUSCITATED. THIRTY MINUTES PRIOR TO THIS EVENT, THE PT'S CENTRAL VENOUS LINE IN THE RIGHT INTERNAL JUGULAR WAS REMOVED AND MOST LIKELY THE VEIN WAS NOT FULLY OCCLUDED WHICH ALLOWED AIR INGRESSION INTO THE RIGHT ATRIUM. THE PT CONTINUES TREATMENT ON A DIFFERENT PRISMAFLEX AND IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMAFLEX KDI GAMBRO LUNDIA AB 114489

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening