BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYSIS UNKNOWN

    MDR report key: 8537871 · Received April 22, 2019

    Report

    Report Number
    3009211636-2019-00099
    Event Type
    Injury
    Date Received
    April 22, 2019
    Report Date
    April 22, 2019
    Manufacturer
    COVIDIEN MFG SOLUTIONS S.A.
    Product Code
    FJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: TRANSJUGULAR TUNNELLED DIALYSIS CATHETER TIP PLACEMENT INTO THE INFERIOR VENA CAVA UPPER SEGMENT AFTER LENGTH OVERESTIMATION SOURCE J VASC ACCESS, VOLUME 16, 2015 (72-75) ARTICLE NUMBER: 1 DATE OF PUBLICATION: 2 SEPTEMBER 2014. (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED INVOLVED A PATIENT UNDERGOING HEMODIALYSIS FOR THREE MONTHS VIA AN INTRA-JUGULAR TUNNELED DIALYSIS CATHETER (IJ-TDC) FROM A DIFFERENT MANUFACTURER (1ST DEVICE) INSERTED AS A RESULT OF PERSISTENT STAPHYLOCOCCAL EXIT SITE INFECTION FROM A PREVIOUS PERITONEAL DIALYSIS (PD) CATHETER. TWO (2) DAYS LATER, THE 1ST IJ-TDC DEVICE EXPERIENCED POOR FLOW AND WAS THEN EXCHANGED/REPLACED WITH ANOTHER CATHETER (2ND DEVICE). THE PATIENT WAS SUBSEQUENTLY DIALYZED UNEVENTFULLY FOR 5 MONTHS WITH A BLOOD FLOW >250 ML/MIN UNTIL HE PRESENTED WITH SEVERE SEPSIS DUE TO STAPHYLOCOCCAL CATHETER-RELATED INFECTION (CRI). THE 2ND CATHETER WAS THEN REMOVED IMMEDIATELY, AND HE WAS DIALYZED VIA A TEMPORARY FEMORAL CATHETER TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328446 DIALYSIS UNKNOWN CATHETER, PERITONEAL, LONG-TERM INDWELLING FJS COVIDIEN MFG SOLUTIONS S.A. DIALYSIS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| R