BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEARUM HS

    MDR report key: 20130842 · Received September 3, 2024

    Report

    Report Number
    1000312731-2024-00011
    Event Type
    Injury
    Date Received
    September 3, 2024
    Date of Event
    August 5, 2024
    Report Date
    September 3, 2024
    Manufacturer
    BELLCO SRL
    Product Code
    KDI
    PMA / PMN Number
    K193542
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    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, THE PATIENT HAD END-STAGE KIDNEY DISEASE. THE PATIENT UNDERWENT REGULAR HEMODIALYSIS; AT 13:59 ON THE EVENT DATE, THE PATIENT PRESENTED WITH PRURITUS ON THE SKIN IN BOTH FEET AND ABDOMINAL PAIN. DEXAMETHASONE SODIUM PHOSPHATE INJECTION (5 MG) WAS IMMEDIATELY ADMINISTERED VIA INTRAVENOUS INJECTION. THE ABOVE SYMPTOMS WERE RELIEVED 20 MINUTES LATER. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. PRIMING WAS DONE WITH NORMAL RESULTS. THERE WAS NO BLOOD LOSS, AND A BLOOD TRANSFUSION WAS NOT PERFORMED. THE PRODUCT WAS REPLACED AS A REMEDIAL ACTION DUE TO THE EVENT AND THE INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THE TREATMENT WAS COMPLETED AFTER THE REMEDIAL ACTION WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369020 CLEARUM HS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SE KDI BELLCO SRL IBP4371 2309000278

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Other