BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEARUM HS

    MDR report key: 19829575 · Received July 25, 2024

    Report

    Report Number
    1000312731-2024-00007
    Event Type
    Injury
    Date Received
    July 25, 2024
    Date of Event
    June 28, 2024
    Report Date
    August 5, 2024
    Manufacturer
    BELLCO SRL
    Product Code
    KDI
    PMA / PMN Number
    K193542
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    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.

    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,30 MINUTES INTO (HD) HEMODIALYSIS TREATMENT, THE PATIENT COMPLAINED OF MILD ABDOMINAL PAIN AND SLIGHT SHORTNESS OF BREATH AND DISCOMFORT. IT WAS ALSO STATED THAT PHYSICAL EXAMINATION SHOWED COARSE BREATH SOUNDS IN BOTH LUNGS, AND NO OBVIOUS RALES WERE HEARD. ULTRAFILTRATION WAS IMMEDIATELY SUSPENDED, AND SYMPTOMATIC TREATMENT SUCH AS DEXAMETHASONE 5 MG VIA INTRAVENOUS PUSH WAS GIVEN. THE ABOVE SYMPTOMS IMPROVED SIGNIFICANTLY AFTER ABOUT 5 MINUTES.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, 30 MINUTES INTO HD (HEMODIALYSIS) TREATMENT, THE PATIENT COMPLAINED OF MILD ABDOMINAL PAIN AND SLIGHT SHORTNESS OF BREATH AND DISCOMFORT. IT WAS ALSO STATED THAT PHYSICAL EXAMINATION SHOWED COARSE BREATH SOUNDS IN BOTH LUNGS, AND NO OBVIOUS RALES WERE HEARD. ULTRAFILTRATION WAS IMMEDIATELY SUSPENDED, AND SYMPTOMATIC TREATMENT SUCH AS DEXAMETHASONE 5 MG VIA INTRAVENOUS PUSH WAS GIVEN AS THE REMEDIAL ACTION REQUIRED TO ADDRESS THE ISSUE. THE ABOVE SYMPTOMS IMPROVED SIGNIFICANTLY AFTER ABOUT 5 MINUTES. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT. PRIMING WAS DONE PRIOR TO USE AND WITH NORMAL RESULTS. BLOOD DIALYZER AND DISPOSABLE BLOOD DIALYSIS PIPE JOINT USAGE WERE THE OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE AND THE INTERVENTION REQUIRED AS A RESULT OF THE EVENT. THE TREATMENT PROCEEDED AND WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253743 CLEARUM HS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SE KDI BELLCO SRL IBP4373 2309000245

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention