BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TABLO HEMODIALYSIS SYSTEM, TABLO CARTRIDGE

    MDR report key: 21014441 · Received December 24, 2024

    Report

    Report Number
    3010355846-2024-00107
    Event Type
    Injury
    Date Received
    December 24, 2024
    Date of Event
    November 27, 2024
    Report Date
    December 24, 2024
    Manufacturer
    OUTSET MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K190793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INCLUDES, BUT ARE NOT LIMITED TO, OTHER, MORE SERIOUS, COMPLICATIONS ARISING FROM DIALYSIS, SUCH AS HEMORRHAGE, AIR EMBOLISM, ACIDOSIS, ALKALOSIS OR HEMOLYSIS, CAN CAUSE SERIOUS PATIENT INJURY OR DEATH. TABLO USER MANUAL HAS THE FOLLOWING WARNING: ENSURE ALL CONNECTIONS ARE SECURE BEFORE USE AND MONITOR FOR LEAKS REGULARLY DURING PATIENT USE. BLOOD LOSS CAN RESULT IF CONNECTIONS ARE NOT SECURE AND DURING THE DIALYSIS TREATMENT, MONITOR THE LINES AND CHECK FOR LEAKS. MACHINE ALARMS MAY NOT OCCUR IN EVERY BLOOD LOSS SITUATION. OUTSET MEDICAL, INC. FIELD SERVICE ENGINEER (FSE) REVIEWED SITE SYSTEM LOG WITH A PROCEDURE DATE OF (B)(6) 2024 AND VERIFIED THAT THERE WAS NO ISSUE WITH THE SYSTEM WHICH CAUSED THE PATIENT EVENT. THE CARTRIDGE WAS DISCARDED; THEREFORE, ROOT CAUSE OF THE EVENT WAS NOT ABLE TO BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A CARTRIDGE FAILURE DURING PATIENT TREATMENT. CARTRIDGE LEAKED NEAR BLOOD PUMP SECTION; HOME PATIENT (HP) DISCOVERED BLOOD ALL OVER THE BACK OF THE CARTRIDGE, TABLO AND FLOOR. AN ESTIMATE OF 300 ML BLOOD LOSS. ON (B)(6) 2024, ADDITIONAL INFORMATION WAS RECEIVED STATING THAT PATIENT WAS HOSPITALIZED AFTER THE EVENT; IT WAS REPORTED THAT THE PATIENT'S HEMOGLOBIN WENT FROM 7.1 G/DL TO 5.8 G/DL NECESSITATING HOSPITALIZATION AND THREE BLOOD TRANSFUSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73285 TABLO HEMODIALYSIS SYSTEM, TABLO CARTRIDGE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OUTSET MEDICAL, INC. M24225L04S01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R