BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUO-FLOW

    MDR report key: 7402303 · Received April 6, 2018

    Report

    Report Number
    7402303
    Event Type
    Malfunction
    Date Received
    April 6, 2018
    Date of Event
    March 6, 2018
    Report Date
    March 30, 2018
    Manufacturer
    MEDICAL COMPONENTS, INC (DBA MEDCOMP)
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT PRESENTED TO THE DIALYSIS UNIT FOR ROUTINE SCHEDULED DIALYSIS. TREATMENT COMPLETE WITHOUT ISSUE. DURING THE RETURN OF BLOOD FROM THE CIRCUIT TO THE PATIENT A LEAK WAS NOTED ON THE VENOUS (BLUE) PORT OF THE HD CATHETER WERE THE BLUE HUB SITS INSIDE CLEAR RUBBER TUBING. STAFF CLAMPED ABOVE AND BELOW THE LEAK. ALL BLOOD WAS SAFELY RETURNED WITHOUT COMPLICATIONS THROUGH THE ARTERIAL PORT. SURGERY WAS CONSULTED AND REPAIRED THE LINE. THE LINE HAD BEEN ORIGINALLY INSERTED APPROXIMATELY 4 MONTHS EARLIER. NEPHROLOGY ATTENDING PHYSICIAN CONSULTED. ANTIBIOTICS WERE PRESCRIBED PROPHYLACTICALLY. BLOOD CULTURES WHERE DRAWN AT THE TIME OF THE LEAK AS WELL AS APPROXIMATELY 3 DAYS LATER. BOTH SETS OF CULTURES WERE NEGATIVE. CIPROFLOXACIN AND VANCOMYCIN WERE PRESCRIBED AND ADMINISTERED. REVIEW OF CASE -- POINT OF LEAKAGE MAY BE DUE TO CATHETER BENDING AT THAT SITE DUE TO PATIENT'S HABITUS. WILL CONTINUE TO MONITOR CATHETER IN FUTURE TREATMENTS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245338 DUO-FLOW CATHETER, HEMODIALYSIS, IMPLANTED MSD MEDICAL COMPONENTS, INC (DBA MEDCOMP) MCDLT4400

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR DIALYSIS| NO