BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMODIALYSIS KIT: 2-L 15 FR X 23 CM

    MDR report key: 3940623 · Received June 25, 2014

    Report

    Report Number
    1036844-2014-00284
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 24, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    MSD
    PMA / PMN Number
    K040078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    THE REPORT WAS RECEIVED VIA ADVERSE INCIDENT REPORT FROM (B)(4). IT WAS REPORTED THE PATIENT UNDERWENT THE INSERTION OF A TUNNELED CENTRAL VENOUS CATHETER TO FACILITATE URGENT HEMODIALYSIS TREATMENT. THE CATHETER WAS INSERTED INTO THE PATIENT'S RIGHT INTERNAL JUGULAR VEIN AND WAS PLACED UNDER ASEPTIC CONDITIONS USING LOCAL ANESTHETIC AND WITH ULTRASOUND GUIDANCE TO IDENTIFY AND CANNULATE THE VEIN. THE PROCEDURE WAS UNDERTAKEN BY A SPECIALIST TRAINEE UNDER THE SUPERVISION OF A VERY SKILLED ASSOCIATE SPECIALIST DOCTOR AND THE PROCEDURE WAS REPORTED TO HAVE BEEN STRAIGHT-FORWARD. IMMEDIATELY AFTER THE PROCEDURE THE PATIENT SUSTAINED A CIRCULATORY COLLAPSE SUCH THAT THE 'CRASH' TEAM WAS CALLED. HE REQUIRED SOME RESPIRATORY SUPPORT BUT DID NOT LOSE HIS CARDIAC OUTPUT. HE WAS RESUSCITATED WITH INTRAVENOUS FLUID AND TRANSFERRED TO ICU. IMMEDIATE INVESTIGATIONS REVEALED A LARGE PERICARDIAL EFFUSION CAUSING TAMPONADE AND HE REQUIRED AN URGENT PERICARDIAL DRAINAGE PROCEDURE WHICH WAS CARRIED OUT AND LED TO A RAPID RECOVERY. THE PATIENT WAS TRANSFERRED TO THE CARDIOTHORACIC UNIT FOR FURTHER MANAGEMENT BUT DID NOT REQUIRE ANY FURTHER SURGICAL INTERVENTION. HE WAS OBSERVED FOR 36 HOURS BEFORE REMOVAL OF THE CARDIAC DRAIN. THE CENTRAL VENOUS CATHETER WAS SHOWN TO BE IN A SATISFACTORY PROCESS AND HAS SUBSEQUENTLY BEEN USED SUCCESSFULLY FOR HEMODIALYSIS. THE ASSUMPTION IS THAT DURING THE INSERTION OF THE CATHETER, AN INJURY WAS SUSTAINED CAUSING PERFORATION OF THE RIGHT ATRIUM PRESUMABLY BY THE GUIDE WIRE USED IN THE INSERTION TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369858 HEMODIALYSIS KIT: 2-L 15 FR X 23 CM CHRONIC HEMODIALYSIS CATHETER PRODUCTS MSD ARROW INTL., INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1