BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEKDUO VENO-VENOUS CANNULA

    MDR report key: 18114854 · Received November 10, 2023

    Report

    Report Number
    2531527-2023-00036
    Event Type
    Injury
    Date Received
    November 10, 2023
    Report Date
    November 10, 2023
    Manufacturer
    CARDIAC ASSIST INC.
    Product Code
    DWF
    PMA / PMN Number
    K160257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1.-A6. NO PATIENT INFORMATION WAS PROVIDED. D4. NO SERIAL NUMBER(S) HAS BEEN PROVIDED, SO UDI AND EXPIRATION DATE COULD NOT BE DETERMINED. H4. AS A SERIAL NUMBER HAS NOT BEEN PROVIDED, MANUFACTURE DATE IS UNKNOWN. H10. LIVANOVA MANUFACTURES THE PROTEKDUO. THE EVENT OCCURRED IN (B)(6). LIVANOVA HAS ATTEMPTED TO GATHER ADDITIONAL INFORMATION ABOUT THE EVENT, INCLUDING DETAILS OF EACH EVENT (E.G. EVENT DATE), THE ALLEGED RELATIONSHIP BETWEEN THE EVENTS AND THE LIVANOVA DEVICE, AND OTHER INFORMATION ABOUT WHAT HAS OCCURRED. DURING A DISCUSSION WITH DR. BREWER, HE INDICATED THAT SPECIFIC DETAILS REGARDING THIS EVENT (E.G. EVENT DATE, PATIENT INFORMATION, DEVICE INFORMATION, ETC.) WERE NOT RECORDED AND COULD NOT BE PROVIDED. DURING THE FOLLOW-UP COMMUNICATION, DR. BREWER INDICATED THAT SEVERE TRICUSPID REGURGITATION WAS IDENTIFIED ON A PATIENT WHO SUFFERED FROM RV DISFUNCTION PRIOR TO SURGERY, AND THE PROTEKDUO NEEDED TO BE RUN AT A HIGHER RATE IN ORDER TO GET SEPTAL BALANCE. THE CUSTOMER DID NOT KNOW THE VALVE CONDITION PRIOR TO IMPLANTATION AND BELIEVES THE DEVICE CONTRIBUTED TO THE REGURGITATION IN SOME WAY. THE PATIENT WAS ON SUPPORT FOR 24-48 HOURS PRIOR TO THE EVENT AND REMAINED ON THE PROTEKDUO FOR 10-14 DAYS FOLLOWING THE EVENT WITHOUT ANY COMPLICATIONS. AT THIS TIME, THERE IS NO KNOWN MALFUNCTION OF THE PROTEKDUO THAT HAS BEEN REPORTED AND IT IS UNCLEAR IF ANY RELATIONSHIP EXISTS BETWEEN THE REPORTED ADVERSE EVENTS AND THE LIVANOVA DEVICE. THE CUSTOMER BELIEVES THE DEVICE CONTRIBUTED IN SOME WAY, BUT NO SPECIFIC MALFUNCTION HAS BEEN IDENTIFIED. AS DEVICE INFORMATION WAS NOT PROVIDED, A REVIEW OF THE DHR COULD NOT BE PERFORMED. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. H3 OTHER TEXT : DEVICE(S) HAS NOT BEEN MADE AVAILABLE.

    Description of Event or Problem · 0

    LIVANOVA RECEIVED A REPORT FROM A PHYSICIAN WHO STATED THAT THEY NOTICED A PATIENT WITH SEVERE PULMONIC INSUFFICIENCY AFTER PLACING THE PROTEKDUO 31FR CANNULA WHILE ON SUPPORT FOR 24-28 HRS. THE PATIENT HAD THE PROTEKDUO REMAIN IN PLACE WITHOUT ANY COMPLICATIONS BUT HAD TO RUN AT A HIGHER SPEED FOR 10-14 DAYS. THE PATIENT WAS REPORTEDLY STILL IN ICU AT THE TIME THE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232315 PROTEKDUO VENO-VENOUS CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF CARDIAC ASSIST INC. 5140-5131

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other