BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOPLEGIA PACKS, PERFUSION TUBING SET, PERFUSION TUBING, TUBING

    MDR report key: 18481983 · Received January 10, 2024

    Report

    Report Number
    1718850-2024-00022
    Event Type
    Malfunction
    Date Received
    January 10, 2024
    Report Date
    March 13, 2024
    Manufacturer
    LIVANOVA INC. USA
    Product Code
    DWE
    UDI-DI
    00803622119880
    PMA / PMN Number
    K920312
    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: THE DHR REVIEW HIGHLIGHTED THAT THE COMPLAINED LOT WAS RELEASED CONFORMING TO PRODUCT SPECIFICATIONS. NO OTHER SIMILAR EVENTS WERE REPORTED ON THIS LOT NUMBER. BASED ON THE ABOVE, THE MOST LIKELY ROOT CAUSE OF THE REPORTED MISASSEMBLY WAS DUE TO AN ISOLATED MANUFACTURING OPERATOR ERROR DURING THE ASSEMBLY PHASE OF THIS CIRCUIT. 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 THE CONVENIENCE PACK. THE INCIDENT OCCURRED IN CLEVELAND, OHIO. LIVANOVA INITIATED AN 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 THAT COLORED (WHITE AND RED) CLAMPS IN THE CARDIOPLEGIA LINE IN 1 UNIT WERE REVERSED. IN PARTICULAR, THEY WERE FLIPPED AND PLACED ON THE WRONG LINE. IT WAS STILL ABLE TO BE USED FOR SURGERY. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1142955 CARDIOPLEGIA PACKS, PERFUSION TUBING SET, PERFUSION TUBING, TUBING TUBING, PUMP, CARDIOPULMONARY BYPASS DWE LIVANOVA INC. USA 627285601 2223700044 00803622119880

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown