BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

    MDR report key: 11066408 · Received December 23, 2020

    Report

    Report Number
    9680841-2020-00018
    Event Type
    Malfunction
    Date Received
    December 23, 2020
    Date of Event
    December 2, 2020
    Report Date
    April 13, 2021
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    LIVANOVA RECEIVED REPORT ABOUT POOR GAS EXCHANGE AT THE BEGINNING OF A BYPASS USING INSPIRE 8F. THERE IS NO REPORT OF ANY PATIENT INJURY. BLOOD GAS REPORT PROVIDED BY THE CUSTOMER DID NOT HAVE RELEVANT INFORMATION ABOUT PRESSURE VALUES NOR OXYGEN SATURATION. HOWEVER, FIO2 IS REPORTED TO BE CONSTANT AT 100%. DHR VERIFICATION DID NOT REVEAL ANY RELEVANT INFORMATION POSSIBLY LINKED WITH THE CLAIMED DEFECT. THE NOTICED LOT WAS NOT INVOLVED IN OTHER SIMILAR COMPLAINTS. BASED ON THE ABOVE INFORMATION, NO SPECIFIC ROOT CAUSE CAN BE ADDRESSED. A POSSIBLE HYPOTHESIS IS THAT THE ISSUE IS MULTI-FACTORIAL, WHERE A COMBINATION OF TRIGGERING FACTORS MIGHT BE ORIGINATING THE PHENOMENON, INCLUDING INTERACTION WITH CLINICAL PROCEDURE AND PATIENT CONDITIONS. THE RISK IS ACCEPTABLE. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY, LIVANOVA WILL KEEP MONITORING THE MARKET.

    Additional Manufacturer Narrative · 0

    INVOLVED UNIT WAS RETURNED TO LIVANOVA FACILITY AND TESTED AS RELEVANT UNI EN ISO STANDARD. LABORATORY TESTS FOUND THE OXYGENATOR PERFORMED AS EXPECTED. IN ADDITION, WATER CONDENSATION PHENOMENON INSIDE MICROPOROUS FIBERS WAS OBSERVED DURING THE LABORATORY TEST. HOWEVER THIS COULD BE RELATED TO HIGH-HUMIDITY STORAGE CONDITIONS. BASED ON ALL GATHERED FACTS, NO DIRECT RELATIONSHIP BETWEEN COMPLAINED EVENT AND ANY POSSIBLE DEVICE-RELATED QUALITY PROBLEM WAS CONFIRMED. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION HAS BEEN PROVIDED. THE INSPIRE 8F OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE EXPIRATION DATE IS PENDING AND REFERS TO THE STERILE FINISHED PRODUCT INTO WHICH THE OXYGENATOR WAS ASSEMBLED. THE UNIQUE IDENTIFIER (UDI) NUMBER OF THE STERILE CONVENIENCE PACK IS PENDING. THE INVOLVED INSPIRE 8F 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 IS PENDING AND REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE OXYGENATOR WAS ASSEMBLED. SORIN GROUP (B)(4)MANUFACTURES THE INSPIRE 8F OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6) UNITED STATES. THE INVOLVED DEVICE HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP (B)(4) FOR INVESTIGATION. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE NOT YET RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) HAS RECEIVED A REPORT THAT, DURING A PROCEDURE, THE BLOOD OF THE PATIENT REMAINED DARK. MEDICAL TEAM ELECTED TO CAME OFF BYPASS AND CHANGED OUT OXYGENATOR. THE PROCEDURE WAS COMPLETED WITH NO ISSUE. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1527320 INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA SRL 2008210002

    Patients

    Seq Age Sex Outcome Treatment
    1