BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 8F HOLLOW FIBER OXYGENATOR

    MDR report key: 12867866 · Received November 24, 2021

    Report

    Report Number
    9680841-2021-00033
    Event Type
    Malfunction
    Date Received
    November 24, 2021
    Date of Event
    October 26, 2021
    Report Date
    March 23, 2022
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    UDI-DI
    008036221334666
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DHR REVIEW OF THE COMPLAINED LOT CONFIRMED THE OXYGENATOR WAS RELEASED CONFORMING TO PRODUCT SPECIFICATION. THE UNIT HAS PASSED THE AIR LEAK TESTS PERFORMED DURING MANUFACTURING BEFORE RELEASE. REVIEW OF THE LIVANOVA COMPLAINT DATABASE DID NOT IDENTIFY ANY OTHER SIMILAR EVENT RELEVANT TO THE LOT OF OXYGENATOR OR HEAT EXCHANGER MODULE THUS EXCLUDING ANY SYSTEMATIC ISSUE. THE COMPLAINED OXYGENATOR WAS RETURNED TO LIVANOVA FOR INVESTIGATION. THE VISUAL INSPECTION FOUND NO OBVIOUS DAMAGE OR CRACK. TO VERIFY THE INTEGRITY OF THE BLOOD AND WATER COMPARTMENTS OF THE COMPLAINED OXYGENATOR, THE UNIT WAS AIR LEAK TESTED IN THE SAME CONDITION AS DURING MANUFACTURING TESTS. THE UNIT PASSED THE AIR LEAK TEST OF BOTH WATER AND BLOOD COMPARTMENT THUS EXCLUDING ANY DAMAGE TO THE TWO COMPARTMENTS. NO DEVICE MALFUNCTION COULD BE CONFIRMED, THE OXYGENATOR BEHAVED AS EXPECTED. THE ROOT CAUSE OF THE ISSUE AT THE CUSTOMER SITE REMAINS UNKNOWN. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Additional Manufacturer Narrative · 0

    THE ISSUE OCCURRED PRIOR TO ANY PATIENT INVOLVEMENT. THE INSPIRE 8F M OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT INTO WHICH THE OXYGENATOR WAS ASSEMBLED. THE UNIQUE IDENTIFIER (UDI) NUMBER OF THE STERILE CONVENIENCE PACK IS (B)(4). THE INVOLVED INSPIRE 8F M OXYGENATOR IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE STANDALONE OXYGENATOR (CATALOG NUMBER 050703) IS ALSO REGISTERED IN THE USA (510(K) NUMBER: K180448). THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE OXYGENATOR WAS ASSEMBLED. SORIN GROUP (B)(4) MANUFACTURES THE INSPIRE 8F M OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6), UNITED STATES. THE INVOLVED DEVICE HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP (B)(4) FOR INVESTIGATION. THE DEVICE HAS NOT YET BEEN RECEIVED IN SORIN GROUP (B)(4). IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. NOT YET RECEIVED.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Description of Event or Problem · 0

    SORIN GROUP (B)(4) HAS RECEIVED A REPORT THAT, DURING SET UP OF A CIRCUIT PRIOR TO A PROCEDURE, THE PERFUSIONIST TURNED ON THE WATER FLOW TO DO THE WATER LEAK TEST AND FOUND THAT WATER FILLED THE TUBING CIRCUIT AND RESERVOIR OF THE INSPIRE OXYGENATOR. THE ISSUE OCCURRED PRIOR TO ANY PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1767361 INSPIRE 8F HOLLOW FIBER OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA SRL 2106250003 008036221334666

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown