BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TABLO(R) HEMODIALYSIS SYSTEM

    MDR report key: 14013730 · Received April 5, 2022

    Report

    Report Number
    14013730
    Event Type
    Malfunction
    Date Received
    April 5, 2022
    Date of Event
    February 8, 2022
    Report Date
    March 9, 2022
    Manufacturer
    OUTSET MEDICAL, INC.
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NO EQUIPMENT ISSUES OR HUMAN FACTORS INTERACTING WITH EQUIPMENT IDENTIFIED.

    Description of Event or Problem · 0

    3 TABLO PUMP FAILURES LEADING TO DELAY OF CARE. ADULT MORBIDLY OBESE FEMALE PT ADMITTED WITH ACUTE KIDNEY INJURY REQUIRING EMERGENT DIALYSIS. PT ALERT, CONFUSED, REQUIRING BILEVEL POSITIVE AIRWAY PRESSURE; HYPOTENSIVE REQUIRING LEVOPHED CONTINUOUS MEDICATION DRIP, DIALYSIS CATHETER IN RIGHT INTERNAL JUGULAR. ON INITIAL START OF CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) THE TABLO MACHINE DISPLAYED ALARM "BYPASS VALVE FAILURE", OUTSET MEDICAL NOTIFIED, TAKEN OUT OF SERVICE, CASE # ASSIGNED. WITH SECOND TABLO MACHINE, FIRST ALARM DISPLAYED "HIGH VASCULAR PRESSURE", MULTIPLE ATTEMPTS AT TROUBLESHOOTING LINE INCLUDING FLUSHING LINE, SWITCHING BLUE/RED LINES, REPOSITIONING PT. VASCATH WAS FOUND TO BE CLOTTED AND REQUIRED INSTILLATION OF HEPARIN AND HEPARIN CONTINUOUS DRIP TO BE STARTED, TREATMENT PAUSED FOR APPROXIMATELY 3 HOURS WAITING FOR LABS AND HEPARIN TO BE DOSED TO BY PHARMACY. SECOND ALARM FROM SAME TABLO MACHINE DISPLAYED "WATER MODULE FAILURE". MACHINE REMOVED FROM PT ROOM, OUTSET NOTIFIED, ABLE TO TROUBLESHOOT OVER THE PHONE AND RESOLVE PROBLEM, THIRD TABLO MACHINE DISPLAYED ALARM OF "INCORRECT BLOOD PUMP RATE"" OUTSET MEDICAL NOTIFIED, INSTRUCTED TO TAKE MACHINE OUT OF SERVICE, CASE # ASSIGNED. 4TH TABLO MACHINE BROUGHT TO BEDSIDE AND WAS ABLE TO INITIATE TREATMENT, TOTAL OF 6 CARTRIDGE/FILTER CHANGES OCCURRED. PT RECEIVED APPROXIMATELY 1.5 HOURS OF CRRT THROUGHOUT THE 12-HOUR SHIFT. POTASSIUM REMAINED CRITICALLY HIGH, WITH MINIMAL URINE OUTPUT THROUGHOUT NIGHT. RECOMMEND HAVING THESE ISSUES RESOLVED SOONER RATHER THAN LATER AS IT IS DELAYING CARE FOR CRITICALLY ILL PATIENTS. THESE ERRORS ARE NOT BEING ABLE TO BE TROUBLESHOOTED BY THE BEDSIDE RN. HOW, IF POSSIBLE, CAN WE PREVENT/LIMIT THESE TROUBLESHOOTING ALARMS FROM RECURRING SO OFTEN?"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840848 TABLO(R) HEMODIALYSIS SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OUTSET MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 17885 DA Female Other