BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIALYSIS UNKNOWN

    MDR report key: 22984014 · Received September 5, 2025

    Report

    Report Number
    1282497-2025-00572
    Event Type
    Death
    Date Received
    September 5, 2025
    Date of Event
    July 23, 2025
    Report Date
    September 5, 2025
    Manufacturer
    COVIDIEN LLC
    Product Code
    FJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    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, ON THE DAY OF THE EVENT, THE PATIENT WAS PRESENTED FOR ROUTINE HEMODIALYSIS. PRETREATMENT VITAL SIGNS WERE BLOOD PRESSURE 95/66, PULSE 103, RESPIRATIONS 18, AND TEMPERATURE 96.4. AT 1:45 PM, THE TREATMENT WAS INITIATED AT A BLOOD FLOW RATE OF 400 ML/MIN. AT 2:30 PM, THE RN (REGISTERED NURSE) NOTED A POOL OF BLOOD ON THE FLOOR NEAR THE PATIENT. UPON EXAMINATION, IT WAS DISCOVERED THE VENOUS (BLUE) HUB OF THE CENTRAL VENOUS CATHETER HAD SEPARATED FROM THE LUMEN. THE HUB REMAINED ATTACHED TO THE BLOODLINE, AND THE HEMACLIP WAS PRESENT ON THE LINE. THE LUMEN WAS CLAMPED. NORMAL SALINE AND OXYGEN WERE GIVEN TO THE PATIENT. THE PATIENT WAS TAKEN TO THE HOSPITAL VIA EMS (EMERGENCY MEDICAL SERVICES). UPON PRESENTATION TO THE EMERGENCY DEPARTMENT, THE PATIENT WAS IN CARDIAC ARREST; HEMOGLOBIN DRAWN AT THE ED (EMERGENCY DEPARTMENT) RESULTED AT 3.6. MULTIPLE INTERVENTIONS WERE ATTEMPTED FOR THE PATIENT, INCLUDING INTUBATION AND ACLS (ADVANCED CARDIAC LIFE SUPPORT) MEDICATION ADMINISTRATION. CONTINUED CPR (CARDIOPULMONARY RESUSCITATION) AND DEFIBRILLATION, AS WELL AS THE ADMINISTRATION OF BLOOD PRODUCTS. DESPITE THESE INTERVENTIONS, SPONTANEOUS CIRCULATION COULD NOT BE ACHIEVED, AND TIME OF DEATH WAS CALLED AT 3:43PM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306896 DIALYSIS UNKNOWN CATHETER, PERITONEAL, LONG-TERM INDWELLING FJS COVIDIEN LLC DIALYSIS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Hospitalization| L| O| D