BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARUM HS

    MDR report key: 20232869 · Received September 16, 2024

    Report

    Report Number
    1000312731-2024-00013
    Event Type
    Malfunction
    Date Received
    September 16, 2024
    Date of Event
    August 7, 2024
    Report Date
    September 24, 2024
    Manufacturer
    BELLCO SRL
    Product Code
    KDI
    PMA / PMN Number
    K193542
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H11 ADDITIONAL INFORMATION: G3 ADDITIONAL REVIEW OF THE EVENT AND/OR ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS IN 21 CFR 803. 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.

    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 BLOOD PURIFICATION NURSE NOTICED THAT THE BYPASS JOINT WAS BROKEN BEFORE THE DIALYZER WAS USED AND IMMEDIATELY STOPPED USING IT WITHOUT CAUSING HARM TO PERSONNEL. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THE REPORTED PRODUCT WAS REPLACED AS A REMEDIAL ACTION AND WAS REPORTED TO THE SUPPLIES OFFICE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2525978 CLEARUM HS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SE KDI BELLCO SRL IBP4371 2309000281

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown