BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARXT TUBING AND CONNECTORS

    MDR report key: 11019093 · Received December 16, 2020

    Report

    Report Number
    1718850-2020-00046
    Event Type
    Injury
    Date Received
    December 16, 2020
    Date of Event
    July 16, 2020
    Report Date
    February 17, 2021
    Manufacturer
    LIVANOVA USA INC
    Product Code
    DWE
    PMA / PMN Number
    K981613
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    LIVANOVA RECEIVED A REPORT STATING THAT A KINK WAS NOTICED IN THE INFLOW AND OUTFLOW LINES OF THE CENTRIFUGAL PUMP DURING THE SET-UP. THE LINED WERE CUT BY THE USER THE PROCEDURE WAS STARTED. AFTER 138 MINUTES AFTER THE BEGINNING OF THE BYPASS, A REDUCTION OF THE FLOW WAS NOTED: THE LINE FROM THE CARDIOTOMY TO THE INLET OF THE CENTRIFUGAL PUMP WAS KINKED. THERE IS NO REPORT OF ANY PATIENT INJURY. FOLLOW UP CLARIFICATION WITH THE CUSTOMER COULD NOT CLARIFY WHY, HAVING THE ISSUE BEEN IDENTIFIED DURING SET-UP, THE USER DECIDED TO MODIFY THE LENGTH OF THE TUBING INSTEAD OF REPLACING THE CIRCUIT. THE AVAILABILITY OF THE INVOLVED HAS NOT BEEN CLARIFIED. THE BATCH OF THE COMPLAINED CIRCUIT WAS NOT PROVIDED. REVIEW OF THE LIVANOVA COMPLAINT DATABASED FOUND ANOTHER SIMILAR EVENT RELATED TO THE SAME CIRCUIT ITEM, OCCURRED THREE DAYS BEFORE THE PRESENT EVENT. INVESTIGATION OF THE PREVIOUS EVENT SUGGESTED THE KINK WAS DUE TO AN OPERATOR ERROR DURING THE MANUAL ASSEMBLY OF THE CIRCUIT AT THE LIVANOVA FACILITIES. TO PREVENT REOCCURRENCE, THE MANUFACTURING PERSONNEL HAS BEEN INFORMED OF THIS ISSUE DURING FORMAL TRAINING MEETING. THE RISK IS ACCEPTABLE. NO OTHER CORRECTIVE ACTION IS DEEMED NECESSARY. LIVANOVA WILL MAINTAIN TO MONITORING THE MARKET. H3 OTHER TEXT : THE AVAILABILITY OF THE INVOLVED HAS NOT BEEN CLARIFIED.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    THE AVAILABILITY OF THE INVOLVED HAS NOT BEEN CLARIFIED. A REVIEW OF THE DHR WAS NOT POSSIBLE AS NO LOT WAS PROVIDED. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    LIVANOVA USA INC. HAS RECEIVED A REPORT THAT AT THE PACKAGING OPENING, A KINK IN THE OUTLET TUBING OF THE PUMP WAS IDENTIFIED. THE KINKED OUTLET TUBING WAS CUT AND SET-UP WAS COMPLETED. THE CUT CAUSED THE LENGTH OF THE INLET AND OUTLET TUBING TO NOT BE ANY LONGER THE SAME LENGTH. AFTER 138 MINUTES AFTER THE BEGIN OF THE BY-PASS WAS INITIATED, A FLOW REDUCTION WAS NOTICED. THE CAUSE WAS FOUND TO BE THAT THE INFLOW FROM THE CARDIOTOMY AND THE INLET OF THE PUMP HAD KINKED. ACCORDING TO MEDICAL TEAM, THIS GENERATED THE FOLLOWING SEQUENCE OF EVENTS, NEGATIVE PRESSURE WAS GENERATED, WHICH CAUSED AIR TO COME OUT FROM SOLUTION, WHICH MOVED TO THE OXYGENATOR AND ARTERIAL LINE, AIR TRIGGERED THE BUBBLE DETECTOR TO STOP THE PUMP. THE SURGEON WAS INFORMED AND ARTERIAL LINE WAS DISCONNECTED, PURGED AND RECONNECTED. PATIENT CONSEQUENCE WERE NOT CLARIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1488151 SMARXT TUBING AND CONNECTORS TUBING, PUMP, CARDIOPULMONARY BYPASS DWE LIVANOVA USA INC

    Patients

    Seq Age Sex Outcome Treatment
    1