BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSION PACK

    MDR report key: 21838100 · Received April 15, 2025

    Report

    Report Number
    1718850-2025-90001
    Event Type
    Malfunction
    Date Received
    April 15, 2025
    Date of Event
    March 18, 2025
    Report Date
    May 22, 2026
    Manufacturer
    LIVANOVA USA INC.
    Product Code
    DWE
    PMA / PMN Number
    K981613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. PATIENT INFORMATION WAS NOT PROVIDED. H11: LIVANOVA USA INC. MANUFACTURES THE PERFUSION PACK. THE INCIDENT OCCURRED IN (B)(6), INDIANA. LIVANOVA INITIATED AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    COMPLAINED DEVICE WAS RETURNED TO MANUFACTURER (LIVANOVA ARVADA) FOR INVESTIGATION AND DECONTAMINATED. VISUAL INSPECTION WAS PERFORMED AND CONFIRM TWO TIE BANDS IN OXYGENATOR INLET PER REPORT DESCRIPTION OF CUSTOMER INSTALLING A SECOND TIE BAND. TIE BANDS WERE INSPECTED AND BOTH CUSTOMER AND LIVANOVA ASSEMBLED TIE BAND WAS FOUND TO BE LOOSE. PRESENCE OF SOLVENT WAS INSPECTED AND WAS FOUND TO BE PRESENT. THE ROOT CAUSE OF THE ISSUE CAN LIKELY BE ATTRIBUTED TO THE LOOSE TIE BAND WITHIN THE INLET PORT CAUSING THE DISCONNECTION OF THE TUBING. 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

    LIVANOVA USA INC. RECEIVED A REPORT THAT THE CONNECTION BETWEEN THE OXYGENATOR INLET PORT AND THE TUBING WAS LOOSE AND BECAME DISCONNECTED DURING PROCEDURE. IT WAS INITIALLY OBSERVED A DRIPPING AT THE OXYGENATOR OUTLET. BEFORE PERFUSIONIST COULD INTERVENE, THE CONNECTION FULLY DETACHED, RESULTING IN A BLOOD SPILL ONTO THE FLOOR. THE PUMP MANAGEMENT WAS MAINTAINED WHILE THE PERFUSIONIST RETRIEVED THE DISCONNECTED TUBING AND REATTACHED IT TO THE OXYGENATOR. DUE TO A LOOSE FIT, THE PERFUSIONIST MANUALLY HELD THE CONNECTION IN PLACE UNTIL A TIE BAND WAS SECURED. THE OXYGENATOR WAS SUCCESSFULLY STABILIZED, AND THE CASE PROCEEDED WITHOUT FURTHER ISSUE. THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 0

    SEE INTIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347087 PERFUSION PACK TUBING, PUMP, CARDIOPULMONARY BYPASS DWE LIVANOVA USA INC. 2432400134

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown