BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIALYSIS UNKNOWN

    MDR report key: 22852526 · Received August 20, 2025

    Report

    Report Number
    1282497-2025-00556
    Event Type
    Death
    Date Received
    August 20, 2025
    Date of Event
    July 14, 2025
    Report Date
    August 20, 2025
    Manufacturer
    COVIDIEN LLC
    Product Code
    MSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D10 - CONCOMITANT PRODUCT: DIALYSIS UNKNOWN, UNK DY, LOT: UNKNOWN DIALYSIS UNKNOWN, UNK DY, LOT: UNKNOWN SEKHAR, JERIN C. ¿CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) PROGRAM INITIATION IN PICU OF A RESOURCE LIMITED SETTING: A RETROSPECTIVE ANALYSIS OF CHALLENGES AND OUTCOMES.¿ BMC NEPHROLOGY, 2025. 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 LITERATURE SOURCE OF STUDY, A SINGLE-CENTER, RETROSPECTIVE OBSERVATIONAL STUDY AT THE PICU (PEDIATRIC INTENSIVE CARE UNIT) WAS CONDUCTED BETWEEN FEBRUARY 2019 AND MAY 2023. THE VASCULAR ACCESS WAS ESTABLISHED USING A DOUBLE-LUMEN DIALYSIS CATHETER, INCLUDING BOTH THE COMPANY'S PRODUCT AND A COMPETITOR'S PRODUCT. CATHETER SIZES INCLUDED 8 FR (FRENCH), 9 FR, 10 FR, AND 11.5 FR. OF THE 2989 PATIENTS ADMITTED TO PICU OVER THE FOUR-YEAR PERIOD, 52 CHILDREN (1.7%) RECEIVED CRRT (CONTINUOUS RENAL REPLACEMENT THERAPY) ACROSS 71 TREATMENT SESSIONS OVER 2556.5 HOURS. OUT OF THE TOTAL PATIENTS WHO UNDERWENT TREATMENT WITH DIFFERENT CATHETER SIZES, 10 PATIENTS WHO USED THE 8 FR CATHETER DID NOT SURVIVE. SIMILARLY, 21 PATIENTS WHO USED THE 9 FR CATHETER DID NOT SURVIVE, FOLLOWED BY 3 PATIENTS WHO USED THE 10 FR CATHETER AND 5 PATIENTS WHO USED THE 11.5 FR CATHETER. IN TOTAL, 39 PATIENTS DIED BEFORE DISCHARGE ACROSS ALL CATHETER SIZES. OUT OF THE 39 PATIENTS WHO DID NOT SURVIVE, TWO PATIENTS DEVELOPED INTRACRANIAL BLEEDING WHILE ON CRRT AND PASSED AWAY. ADDITIONALLY, ONE PATIENT EXPERIENCED CARDIAC ARREST DURING THE BLOOD RETURN PHASE OF CRRT AND PASSED AWAY. LABORATORY RESULTS REVEALED A POST-ARREST SERUM POTASSIUM LEVEL OF 8.1 MEQ/L (MILLIEQUIVALENTS PER LITER), INDICATING SEVERE HYPERKALEMIA. ONE PATIENT, DIAGNOSED WITH ACUTE LEUKEMIA AND TUMOR LYSIS SYNDROME, WAS DISCHARGED FROM THE HOSPITAL AFTER CRRT BUT DIED 0.2 YEARS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1468801 DIALYSIS UNKNOWN CATHETER, HEMODIALYSIS, IMPLANTED MSD COVIDIEN LLC DIALYSIS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Unknown Death| L| O SEE H11 NOTES