BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOPLEGIA PACK

    MDR report key: 20830131 · Received December 3, 2024

    Report

    Report Number
    1718850-2024-00045
    Event Type
    Injury
    Date Received
    December 3, 2024
    Date of Event
    November 4, 2024
    Report Date
    February 26, 2025
    Manufacturer
    LIVANOVA USA INC.
    Product Code
    DWE
    UDI-DI
    00803622142550
    PMA / PMN Number
    K981613
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: BY REVIEWING THE COMPLAINTS DATABASE, NO FURTHER SIMILAR EVENTS HAVE BEEN RECORDED ON THIS PERFUSION TUBING SYSTEM (PTS) CATALOGUE NUMBER NOR A CONCERNING TREND HAS BEEN IDENTIFIED. REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE AFFECTED LOT DID NOT REVEAL ANY DEVIATION OR NON-CONFORMITY. BASED ON THE AVAILABLE INFORMATION AND WITHOUT THE PART TO INVESTIGATE THE ROOT CAUSE OF THE EVENT CANNOT BE ESTABLISHED. CONSIDERING THAT NO ISSUE OCCURRED DURING PRIMING, IT IS UNLIKELY THAT A DEFECTIVE COMPONENT OR CONNECTION WAS INITIALLY PRESENT ON THE CARDIOPLEGIA LINE, BUT A DEFECT COULD HAVE ORIGINATED DUE TO STRESSES AND MANIPULATION APPLIED DURING PROCEDURE.

    Additional Manufacturer Narrative · 0

    A.1.-A.5. PATIENT INFORMATION WAS NOT PROVIDED. H11: LIVANOVA USA INC. MANUFACTURES THE CARDIOPLEGIA PACK. THE INCIDENT OCCURRED IN (B)(6). THROUGH FOLLOW-UP COMMUNICATION LIVANOVA LEARNED THAT THE AFFECTED UNIT IS NOT AVAILABLE FOR INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Description of Event or Problem · 0

    LIVANOVA USA INC. RECEIVED A REPORT RELATED TO AN AIR INGRESS INTO A PERFUSION TUBING SYSTEM (PTS) PACK. IN DETAIL, CARDIOPLEGIA LINE WAS PRIMED AND FLUSHED WITH NO LEAKS NOTED WHEN OVER-PRESSURIZED WHILE IN PRIMING MODE. ONCE CROSS CLAMP WAS ON, WHILE DELIVERING THE CARDIOPLEGIA SOLUTION TO THE PATIENT, THE DELIVERY SYSTEM AND LINE FILLED WITH AIR. DELIVERY WAS THEN STOPPED AND ATTEMPTED TO FLUSH AIR TO THE FIELD. HOWEVER, MORE AIR CAME INTO DELIVERY SYSTEM. THEREFORE, CROSS CLAMP WAS REMOVED. PATIENT WAS DEFIBRILLATED AND CARDIOPLEGIA SYSTEM WAS EXCHANGED FOR NEW ONE. NEW CARDIOPLEGIA CIRCUIT WAS PRIMED AND FLUSHED TO THE FIELD. CROSS CLAMP WAS PLACED AND CARDIOPLEGIA WAS DELIVERED WITH NO AIR ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1414933 CARDIOPLEGIA PACK SMART, PERFUSION TUBING PACKS DWE LIVANOVA USA INC. 2405900038 00803622142550

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention