BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBING

    MDR report key: 19258863 · Received May 7, 2024

    Report

    Report Number
    1718850-2024-00029
    Event Type
    Malfunction
    Date Received
    May 7, 2024
    Date of Event
    June 20, 2024
    Report Date
    November 27, 2024
    Manufacturer
    LIVANOVA USA INC.
    Product Code
    DWE
    PMA / PMN Number
    K881330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. PATIENT INFORMATION WAS NOT PROVIDED. D.4. LOT NUMBER IS UNKNOWN. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. H.4. AS THE LOT NUMBER IS UNKNOWN, THE DEVICE MANUFACTURE DATE COULD NOT BE DETERMINED. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. H10: LIVANOVA USA INC. MANUFACTURES THE TUBING. THE INCIDENT OCCURRED IN (B)(6). THROUGH FOLLOW-UP COMMUNICATION IT WAS LEARNED THE FOLLOWING FINDINGS: THE LINE WAS NOT USED FOR CARDIOPLEGIA DELIVERY. THE LIVANOVA S5 ROLLER PUMP WAS USED IN COMBINATION WITH INVOLVED LINE. THE CUSTOMER DOES NOT USE TWO TUBINGS IN THE SAME RACEWAY NOW. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    A.1.-A.5. PATIENT INFORMATION WAS NOT PROVIDED. D.4. LOT NUMBER IS UNKNOWN. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. H.4. AS THE LOT NUMBER IS UNKNOWN, THE DEVICE MANUFACTURE DATE COULD NOT BE DETERMINED. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. H10: LIVANOVA USA INC. MANUFACTURES THE TUBING. THE INCIDENT OCCURRED IN WYNNEWOOD, PENNSYLVANIA. THROUGH FOLLOW-UP COMMUNICATION IT WAS LEARNED THAT NO PHOTO OR VIDEO OF THE EVENT ARE AVAILABLE AND THAT THE UNIT WAS DISCARDED BY THE CUSTOMER. 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 DISCARDED BY THE CUSTOMER

    Additional Manufacturer Narrative · 0

    H11: AFFECTED PACK CATALOGUE NUMBER ONLY INCLUDES 120" OF 1/4X1/16 PVC TUBING (ACCESSORY LINE). COMPLAINTS HISTORY REVIEW WAS CARRIED OUT AND NO SIMILAR CASE WAS REPORTED FOR NOTICED PACK CATALOGUE NUMBER, NEITHER A CONCERNING TREND HAS BEEN IDENTIFIED. BASED ON THE COLLECTED INFORMATION AND WITHOUT THE PART AVAILABLE FOR INVESTIGATION, IT CANNOT BE RULED OUT THAT AN INCORRECT TUBING SET-UP IN THE RACEWAY HAD OCCURRED, NOR THAT AN INITIAL DEFECT ON THE TUBING WAS PRESENT AND WAS ENHANCED DURING PROCEDURE, LEADING TO ITS RUPTURE.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Description of Event or Problem · 0

    LIVANOVA USA INC. RECEIVED A REPORT A 1/4" LIVANOVA TUBING RUPTURED IN AN S5 LARGE ROLLER PUMP, AT THE END OF A LONG PUMP RUN. THE CUSTOMER USED A COMPETITOR PERFUSION TUBING SYSTEM PACK, AND HAD REPLACED THE AFFECTED TUBING WITH A 1/4" COMPETITOR ONE IN THE SAME RACEWAY.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641856 TUBING TUBING DWE LIVANOVA USA INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown