BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM RETR

    MDR report key: 11863095 · Received May 21, 2021

    Report

    Report Number
    9680794-2021-00224
    Event Type
    Death
    Date Received
    May 21, 2021
    Date of Event
    May 4, 2021
    Report Date
    May 4, 2021
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    MSD
    PMA / PMN Number
    K141051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). IT WAS REPORTED THAT THE ACTUAL DEVICE WAS NOT AVAILABLE FOR RETURN; HOWEVER, THE CUSTOMER DID PROVIDE ONE PHOTO FOR EVALUATION. THE PHOTO DISPLAYED AN X-RAY IMAGE OF A CATHETER IN A PATIENT. THE CATHETER CONTAINED A LARGE BEND AND A SMALL KINK WAS FOUND IN THE CENTER. A FULL VISUAL INSPECTION COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE INSTRUCTIONS-FOR-USE PROVIDED WITH THIS KIT CAUTIONS THE USER, "DO NOT CREATE A SHARP BEND IN CATHETER TUNNEL; KINKING AND REDUCED FLOW WILL RESULT." THE CUSTOMER REPORT OF A CATHETER KINKING DURING USE WAS CONFIRMED BY VISUAL INSPECTION OF THE CUSTOMER SUPPLIED PHOTO. THE CATHETER CONTAINED A LARGE BEND AND A SMALL KINK WAS DETECTED NEAR THE CENTER. HOWEVER, COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE, THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED CATHETER KINKED AFTER INSERTION. CATHETER SHOWED RADIOGRAPHICALLY VISIBLE KINK IN THE INFERIOR LUMEN. CATHETER FLUSHED SUCCESSFULLY ON TESTING, BUT THEN FAILED ON ATTEMPT TO DIALYSE. PATIENT WAS CRITICALLY UNWELL REQUIRING IMMEDIATE DIALYSIS. PATIENT DIED AS A SEQUALAE OF HYPERKALEAEMIA AND METABOLIC ACIDOSIS APPROXIMATELY 6 HOURS AFTER THE LINE WAS PLACED AND COULD NOT BE DIALYSED THROUGH. IT WAS REPORTED THE PATIENT'S CONDITION HAD DETERIORATED PRIOR TO CATHETER INSERTION.

    Additional Manufacturer Narrative · 1

    QN# (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED CATHETER KINKED AFTER INSERTION. CATHETER SHOWED RADIOGRAPHICALLY VISIBLE KINK IN THE INFERIOR LUMEN. CATHETER FLUSHED SUCCESSFULLY ON TESTING, BUT THEN FAILED ON ATTEMPT TO DIALYSE. PATIENT WAS CRITICALLY UNWELL REQUIRING IMMEDIATE DIALYSIS. PATIENT DIED AS A SEQUALAE OF HYPERKALEAEMIA AND METABOLIC ACIDOSIS APPROXIMATELY 6 HOURS AFTER THE LINE WAS PLACED AND COULD NOT BE DIALYSED THROUGH. IT WAS REPORTED THE PATIENT'S CONDITION HAD DETERIORATED PRIOR TO CATHETER INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758659 ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM RETR CATHETER, HEMODIALYSIS, IMPLA MSD ARROW INTERNATIONAL INC. 13F20J0757

    Patients

    Seq Age Sex Outcome Treatment
    1 Death N/A.| N/A.