BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEARUM HS

    MDR report key: 20055260 · Received August 23, 2024

    Report

    Report Number
    1000312731-2024-00009
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    July 24, 2024
    Report Date
    August 23, 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 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, ON THE DAY OF THE EVENT AT 12:00 A.M., THE PATIENT STARTED TO UNDERGO DIALYSIS. THE PATIENT PRESENTED WITH CHEST TIGHTNESS AND SHORTNESS OF BREATH 15 MINUTES AFTER BEING ON THE MACHINE. PHYSICAL EXAMINATION SHOWED: TEMPERATURE 36.5°C, P82 BEATS/MIN, RESPIRATORY RATE 22 BEATS/MIN, AND BP 142/82 MMHG. AFTER SYMPTOMATIC TREATMENT, THE PATIENT REPORTED AN IMPROVEMENT OF SYMPTOMS. PRIMING WAS DONE, AND THE RESULT WAS NORMAL. THERE WAS NO ALARM/ERROR CODE ACTIVATED/DISPLAYED. THERE WERE NO VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THE DEVICE WAS REPLACED WITH A PRODUCT FROM THE SAME LOT AND ID, AND THE PATIENT'S DIALYSIS WAS CONTINUED AND SUCCESSFULLY COMPLETED AFTER FOUR HOURS. THE TREATMENT CONTINUED AFTER THE REPORTED PRODUCT WAS REPLACED WITH THE SAME LOT NUMBER AND ID. AS AN INITIAL TREATMENT, THE PATIENT RECEIVED LOW-FLOW OXYGEN AND DEXAMETHASONE 5 MG (MILLIGRAM) VIA INTRAVENOUS PUSH AS PRESCRIBED BY THE DOCTOR. THERE WAS NO BLOOD LOSS AND NO BLOOD TRANSFUSION PERFORMED. IT WAS STATED THAT THE ALLERGIC REACTION WAS MILD AND THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1699173 CLEARUM HS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SE KDI BELLCO SRL IBP4372 2309000202

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention| O