BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEARUM HS

    MDR report key: 20278575 · Received September 23, 2024

    Report

    Report Number
    1000312731-2024-00015
    Event Type
    Injury
    Date Received
    September 23, 2024
    Date of Event
    August 29, 2024
    Report Date
    September 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

    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 13:45, THE PATIENT WAS GIVEN A HEMODIALYSIS TREATMENT WITH THE REPORTED DEVICE ACCORDING TO THE DOCTOR'S INSTRUCTIONS. THE MEDICAL STAFF OPERATED WITH THE NORMAL PROCESS. THE EXTRACORPOREAL CIRCUIT WAS PREFILLED WITH 0.9% SODIUM CHLORIDE IN 1,000 ML. AFTER EXHAUSTING THE AIR, THE PATIENT WAS PLACED ON THE MACHINE FOR HEMODIALYSIS TREATMENT. THE PATIENT EXPERIENCED AN ALLERGIC REACTION WHILE USING THE HEMODIALYSIS FILTER. AROUND 13:58 PM, THE PATIENT PRESENTED WITH CHEST TIGHTNESS AND SHORTNESS OF BREATH; DIZZINESS; AND BLOOD PRESSURE DECREASED TO 98/56 MMHG. THE PATIENT WAS GIVEN OXYGEN IMMEDIATELY. 60 ML OF 50% GLUCOSE AND 5 MG DEXAMETHASONE SODIUM PHOSPHATE INJECTION WERE INJECTED INTRAVENOUSLY, AND THE BLOOD TUBE WAS DISCONNECTED, AND DEXAMETHASONE SODIUM PHOSPHATE INJECTION (5 ML) WAS ADMINISTERED IN A CLOSED TUBE. ABOUT 20 MINUTES LATER, THE PATIENT COMPLAINED OF CHEST TIGHTNESS, SHORTNESS OF BREATH, AND DIZZINESS WAS RELIEVED, AND THE BLOOD PRESSURE ROSE TO 142/76 MMHG. THE TREATMENT WAS CONTINUED AND COMPLETED AFTER CHANGING THE REPORTED PRODUCT. PRIMING WAS DONE WITH A NORMAL RESULT. AN ANTICOAGULANT WAS ADMINISTERED. THERE WAS NOTHING UNUSUAL OBSERVED ON THE PRODUCT PRIOR TO USE. THERE WAS NO ALARM/ERROR CODE ACTIVATED OR DISPLAYED. BESIDES THE REPORTED ISSUE, THERE WERE NO VISIBLE DEFECTS OR DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT PERFORMED. THE SUBSEQUENT PROCESS WENT SMOOTHLY UNTIL DISEMBARKATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1487635 CLEARUM HS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SE KDI BELLCO SRL IBP4371 2401000198

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Required Intervention| O