BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAMODIALYSIS KIT: 2-L 15 FR X 32 CM

    MDR report key: 2537793 · Received March 27, 2012

    Report

    Report Number
    1036844-2012-00085
    Event Type
    Injury
    Date Received
    March 27, 2012
    Date of Event
    February 17, 2012
    Report Date
    March 26, 2012
    Manufacturer
    ARROW INTL., INC.
    Product Code
    MSD
    PMA / PMN Number
    K040078
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    COMPLAINT WAS RECEIVED VIA MEDWATCH REPORT. IT HAS BEEN REPORTED THAT THE PROCEDURE WAS BEING PERFORMED ON A (B)(6) MALE, PT WITH MULTIPLE MEDICAL PROBLEMS INCLUDING (B)(6) STATUS POST LIVER TRANSPLANT IN 2007, STATUS POST SURGICAL REPAIR OF AN INCISIONAL HERNIA ON (B)(6) 2012 COMPLICATED BY POSTOPERATIVE BLEEDING AND HYPOXIC RESPIRATORY FAILURE, MULTIPLE INFECTIONS AND DIALYSIS DEPENDENT RENAL FAILURE. ON (B)(6) 2012, VASCULAR SURGERY INSERTED A RIGHT INTERNAL JUGULAR TUNNELED HEMODIALYSIS CATHETER WITHOUT COMPLICATION. COMPLETION FILMS IN THE OPERATING ROOM SHOWED THE CATHETER TO BE WELL POSITIONED. HOWEVER, IN THE POST OPERATIVE PERIOD, THERE WERE HIGH PRESSURES ON THE VENOUS SIDE OF THE CATHETER. POST PROCEDURE RADIOGRAPHS REVEALED WHAT APPEARED TO BE A KINK AT THE BASE OF THE NECK, NOT EVIDENT ON INTRA-OPERATIVE FILMS. BECAUSE OF THE POOR FUNCTION OF THE CATHETER AND THE PT'S NEED FOR DIALYSIS, HE WAS RETURNED BY VASCULAR SURGERY TO THE OPERATING ROOM ON (B)(6) 2012 FOR EXPLORATION OF THE CATHETER. AFTER INCISION AND EXPOSURE, THE CATHETER WAS CONTROLLED AND EXAMINED. THERE WAS A KINK ON THE LESSER CURVATURE OF THE CATHETER, CLEARLY VISIBLE AT THE BASE OF THE NECK. THE CATHETER APPEARED TO BE TWISTED IN ITS TUNNEL. THE CRIMP IN THE CATHETER PERSISTED DESPITE MULTIPLE MANIPULATIONS AND THEREFORE, THE CATHETER WAS EXCHANGED. RADIOGRAPHS DEMONSTRATED THAT THE NEW CATHETER WAS POSITIONED PROPERLY AND IT HAS BEEN SUCCESSFULLY UTILIZED FOR DIALYSIS SINCE INSERTION. THE PT REMAINS IN THE SURGICAL INTENSIVE CARE UNIT, IN CRITICAL BUT STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAMODIALYSIS KIT: 2-L 15 FR X 32 CM CHRONIC HEMODIALYSIS CATHETER PRODUCTS MSD ARROW INTL., INC. RF1057371

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention