BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TABLO CARTRIDGE

    MDR report key: 11974163 · Received June 10, 2021

    Report

    Report Number
    11974163
    Event Type
    Malfunction
    Date Received
    June 10, 2021
    Date of Event
    May 21, 2021
    Report Date
    May 26, 2021
    Manufacturer
    OUTSET MEDICAL, INC.
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NURSE WAS DISCONNECTING PATIENT FROM TABLO MACHINE, MACHINE WAS SHUT DOWN WITH CARTRIDGE STILL LOADED. AFTER COMPLETING DISCONNECTION AND DISCHARGING PATIENT NURSE REBOOTED MACHINE. RN BEGAN UNLOADING SYSTEM SET UP. WHILE DRAINING THE DIALYZER NURSE NOTED SIGNIFICANT AMOUNT OF SALINE/BLOOD LEAKING OUT OF THE CARTRIDGE AND ONTO THE FLOOR. UPON ASSESSMENT, THE CENTER CIRCULAR PIECE (LIKELY THE TRANSDUCER) HAD SPLIT INTO TWO PIECES. MANUFACTURER RESPONSE FOR TABLO CARTRIDGE, (BRAND NOT PROVIDED) (PER SITE REPORTER): DEVICE WAS TAKEN FROM FACILITY WITHOUT OUR KNOWLEDGE. THE SECOND INCIDENT OCCURRED WITH MACHINE #1 AT THE END OF TREATMENT. THE PATIENT WAS ABLE TO COMPLETE TREATMENT WITHOUT ISSUE. AFTER THE NURSE RINSED BACK THE PATIENT, THE MACHINE JUST SHUT DOWN ON ITS OWN. ONCE THE PATIENT WAS DISCHARGED FROM THE UNIT, THE NURSES TURNED THE MACHINE BACK ON AND WHEN IT TRIED TO DRAIN THE DIALYZER, THE NURSE NOTICED THE CARTRIDGE LEAKING BLOOD/SALINE ONTO THE FLOOR. AS THIS IS A CLOSED SYSTEM, THIS SHOULD NOT OCCUR. WHEN THE NURSE REMOVED THE CARTRIDGE, IT WAS NOTED THAT THE ROUND PLASTIC COVER ON THE PRESSURE POD POPPED RIGHT OFF. THIS MADE US WONDER IF THIS LOT # OF CARTRIDGES MIGHT HAVE AN ISSUE AND COULD HAVE BEEN THE CAUSE FOR AIR IN THE SYSTEM WITH THE LAST INCIDENT. WE THEREFORE LOOKED AT THE LOT # OF THE CARTRIDGE FROM THE FIRST INCIDENT AND NOTED THEM TO BE THE SAME. WE THEN SEQUESTERED THIS CARTRIDGE (CURRENTLY IN A BIOHAZARD BAG IN OUR LAB ROOM IN THE DIALYSIS UNIT). THERE WAS NO MACHINE ISSUE, SO THE MACHINE WAS NOT PULLED OUT OF ROTATION. WE WERE CONCERNED THAT THERE COULD BE A ¿STRIKETHROUGH¿ MEANING BLOOD POTENTIALLY COULD HAVE BEEN LEAKED INTO THE TRANSDUCER, BUT SINCE THIS MACHINE IS ONLY USED FOR THE SAME PATIENT, IT WAS NOT PULLED. TABLO WAS MADE AWARE OF THE INCIDENT ON FRIDAY AND ARE SENDING THEIR BIOMED TO ENSURE THERE WAS NO STRIKETHROUGH, HE SHOULD BE COMING THIS EVENING. THE PATIENT HAD A TREATMENT TODAY WITH THIS MACHINE, A DIFFERENT CARTRIDGE AND HAD NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868973 TABLO CARTRIDGE SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK OUTSET MEDICAL, INC. K20M248

    Patients

    Seq Age Sex Outcome Treatment
    1