BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TABLO(R) HEMODIALYSIS SYSTEM

    MDR report key: 14013725 · Received April 5, 2022

    Report

    Report Number
    14013725
    Event Type
    Malfunction
    Date Received
    April 5, 2022
    Date of Event
    February 6, 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

    THE PATIENT'S ARTERIAL CATHETER WAS CLAMPED PER INSTRUCTIONS. THE TABLO COMPUTER ALARMED SAYING THE PATIENT LINE WAS NOT CLAMPED. I ENSURED THE CLAMP WAS CLOSED. I THEN ATTEMPTED TO CONTINUE. THE SAME ALARM WAS SOUNDED. I THEN MANUALLY HELD DOWN THE CLAMP TIGHTLY. THE TABLO ATTEMPTED TO SEND THE BLOOD BACK TO THE PATIENT, BUT THE BLOOD WAS NOT BEING PULLED OR PUSHED THROUGH THE LINE, THUS NOT RETURNING TO THE PATIENT, DESPITE THE COMPUTER "SHOWING" IT WAS BEING RETURNED. I ATTEMPTED TO MANUALLY RETURN THE BLOOD. THE TABLO THEN SOUNDED AN ALARM AND FORCE SHUT DOWN. WHEN THE TABLO TURNED BACK ON, IT SHOWED A COMPLETE CYCLE. DUE TO TIME AND INABILITY TO GET THE BLOOD MANUALLY RETURNED I NOTIFIED THE PROVIDER THE BLOOD IN THE LINE WAS NOT RETURNED TO THE PATIENT. HE INSTRUCTED TO DRAW MORNING LABS AND CHECK HEMOGLOBIN. VITALS WERE STABLE. HEMOGLOBIN (HGB) DID HAVE A DROP FROM 7.5 TO 6.8. THE PROVIDER ORDERED 1 UNIT OF BLOOD TO BE GIVEN." NURSE HAD THIS ISSUE TWO TIMES. THE FIRST SHE CALLED RN AND THEY DISCOVERED THE NURSE HAD THE WRONG CLAMP CLAMPED. THE NURSE WAS EDUCATED AND INSTRUCTED TO USE THE CLAMP ON THE PATIENT CATHETER. THE NEXT RUN THE NURSE CLAMPED THE CORRECT CLAMP BUT THE MACHINE GAVE THE SAME ALARM. THE MACHINE WAS ACTING LIKE THE BLOOD WAS BEING RETURNED TO THE PATIENT BUT IN FACT, WAS NOT. THEY TRIED TO MANUALLY GIVE BACK BLOOD BUT EVENTUALLY THE MACHINE FORCED A SHUT DOWN AND THE BLOOD WAS WASTED. DUE TO THE HGB DROP, BLOOD PRODUCTS WERE NEEDED. TABLO MACHINE WAS TAKEN OUT OF SERVICE TO BE LOOKED AT. THERE IS NO ASSOCIATED SERVICE REPORT FROM TABLO FOR REFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527500 TABLO(R) HEMODIALYSIS SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OUTSET MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 27375 DA Male