BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PTS TUBING PACK

    MDR report key: 18650401 · Received February 6, 2024

    Report

    Report Number
    1718850-2024-00023
    Event Type
    Malfunction
    Date Received
    February 6, 2024
    Date of Event
    January 9, 2024
    Report Date
    April 18, 2024
    Manufacturer
    LIVANOVA USA INC.
    Product Code
    DWE
    PMA / PMN Number
    K881330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: REVIEW OF THE COMPLAINTS DATABASE REVEALED NO FURTHER SIMILAR EVENT OCCURRED ON THIS PERFUSION TUBING SYSTEM (PTS) PACK CODE OR LOT NUMBER. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT WAS AN ISOLATED MANUFACTURING OPERATOR ERROR DURING THE ASSEMBLY PHASE OF THIS PTS. TO PREVENT RE-OCCURRENCE, THE MANUFACTURING PERSONNEL HAS BEEN INVOLVED IN A DEDICATED TRAINING MEETING TO DISCUSS THE SPECIFIC EVENT.

    Additional Manufacturer Narrative · 0

    A.1.-A.5. THERE WAS NO PATIENT INVOLVEMENT. H.10. LIVANOVA USA INC MANUFACTURES PTS TUBING PACK. THE INCIDENT OCCURRED IN CINCINNATI, OHIO. THE INVOLVED DEVICE IS NOT AVAILABLE FOR INVESTIGATION. LIVANOVA INITIATED AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. H3 OTHER TEXT : DEVICE NOT AVAILABLE.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Description of Event or Problem · 0

    LIVANOVA USA INC. RECEIVED A REPORT THAT DURING PRIMING IT WAS NOTED THAT IN 1 UNIT CARDIOPLEGIA CLAMPS (RED AND WHITE) WERE ON THE WRONG TUBINGS ON ONE BRIDGE OF THE DOUBLE BRIDGE SYSTEM. THIS AFFECTED UNIT WAS DISCARDED BY THE CUSTOMER AND REBUILT IT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541784 PTS TUBING PACK PERFUSION TUBING SET DWE LIVANOVA USA INC. 044071400 2329100072

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown