BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEARUM HS

    MDR report key: 23468631 · Received November 4, 2025

    Report

    Report Number
    1000312731-2025-00021
    Event Type
    Injury
    Date Received
    November 4, 2025
    Date of Event
    October 14, 2025
    Report Date
    November 4, 2025
    Manufacturer
    BELLCO SRL
    Product Code
    KDI
    UDI-DI
    08051736003607
    PMA / PMN Number
    K193542
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, A BLOOD LEAK IN DIALYSATE CONNECTION WAS CONFIRMED AFTER THE START OF THE DIALYSIS SESSION. AN ALARM BLOOD IN DIALYSATE LEAK ON GENERATOR WAS ALSO ACTIVATED. PATIENT WAS UNPLUGGED WITHOUT RETURN, AND THIS RESULTED IN SIGNIFICANT BLOOD LOSS OF 250-300 MILLILITERS AND A DROP IN ARTERIAL BLOOD PRESSURE BEFORE THE PATIENT¿S DISCHARGE AND THE PATIENT WAS NOT RESTITUTED, AND END OF THE TREATMENT. THE PATIENT HAD TO BE INFUSED WITH 500 MILLILITERS OF NACL AND WAS KEPT UNDER OBSERVATION BEFORE DISCHARGE. THE GENERATOR AND DIALYSIS CIRCUIT WERE CHANGED, AND ALSO THE DIALYZER OF THE SAME TYPE. IMMOBILIZED GENERATORS DESCENDED TO THE TECHNICAL DEPARTMENT FOR VERIFICATION AND DISINFECTION. TECHNICAL INTERVENTIONS ON THE GENERATOR WAS NECESSARY WITH FIBRIN AND BLOOD FOUND IN SOME COMPONENTS. THERE WAS NO BLOOD TRANSFUSION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1817113 CLEARUM HS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SE KDI BELLCO SRL IBP4373 2411000099 08051736003607

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O