BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDISYSTEMS HEMODIALYSIS BLOOD TUBING SETS

    MDR report key: 6135057 · Received November 30, 2016

    Report

    Report Number
    6135057
    Event Type
    Injury
    Date Received
    November 30, 2016
    Date of Event
    October 17, 2016
    Report Date
    November 2, 2016
    Manufacturer
    MEDISYSTEMS CORPORATION
    Product Code
    FJK
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AN INFANT MALE HAD RECEIVED APPROXIMATELY 3 HOURS, 20 MINUTES OF HEMODIALYSIS (HD) WITH 15 MINUTES LEFT IN TREATMENT WHEN BLOOD WAS NOTED TO BE LEAKING PROFUSELY FROM THE ARTERIAL LINE OF CIRCUIT (NOT AT CONNECTION BUT FROM BODY OF TUBING). BLOOD PUMP WAS IMMEDIATELY STOPPED BUT WITH CONTINUED LEAKING. PATIENT WAS RE-INFUSED HIS BLOOD IN THE DIALYSIS CIRCUIT WHILE A STERILE GAUZE WAS HELD TIGHTLY OVER THE LEAK. THE PATIENT REQUIRED 90 ML OF 5% ALBUMIN TO STABILIZE BLOOD PRESSURE. THE PATIENT'S HEMOGLOBIN DROPPED FROM 7.7 TO 6.5. IT WAS NECESSARY TO RE-INITIATE HD ON A NEW SYSTEM TO ALLOW FOR THE TRANSFUSION OF PACKED RED BLOOD CELLS. THE PATIENT WAS TREATED FOR POSSIBLE CONTAMINATION INFECTION WITH VANCOMYCIN AND CIPRO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787237 MEDISYSTEMS HEMODIALYSIS BLOOD TUBING SETS SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK MEDISYSTEMS CORPORATION B3-6604M6792

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Other| R DIALYSIS| THE PATIENT WAS ON HEMODIALYSIS MACHINE AT THE TIM