BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR

    MDR report key: 8659179 · Received May 31, 2019

    Report

    Report Number
    9680841-2019-00021
    Event Type
    Malfunction
    Date Received
    May 31, 2019
    Date of Event
    May 2, 2019
    Report Date
    August 22, 2019
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SORIN GROUP ITALIA MANUFACTURES THE INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER. THE INCIDENT OCCURRED IN (B)(6). BOTH WATER AND BLOOD COMPARTMENTS OF THE RETURNED COMPLAINED OXYGENATOR HAS BEEN LEAK TESTED AND NOT LEAK COULD BE REPRODUCED. DHR OF THE BATCH OF THE OXYGENATOR DID NOT HIGHLIGHT ANY ISSUE POSSIBLY RELATED TO THE CLAIMED DEFECT: THE CLAIMED LOT WAS RELEASED COMPLIANT TO PRODUCT SPECIFICATIONS. THE ISSUE DESCRIBED BY THE CUSTOMER IS NOT REFERABLE TO ANY DEVICE FAILURE: THE OXYGENATOR BEHAVED AS EXPECTED. LIVANOVA WILL KEEP MONITORING THE MARKET FOR SIMILAR EVENTS.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. THE INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER 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 AGE OF THE DEVICE WAS CALCULATED AS THE TIME ELAPSED BETWEEN DEVICE STERILIZATION AND THE DATE OF EVENT. (B)(4). PMA/510(K). THE INVOLVED INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE STAND ALONE OXYGENATOR (CATALOG NUMBER 050703) IS ALSO REGISTERED IN THE USA (510(K) NUMBER: K130433). 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 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER. THE INCIDENT OCCURRED IN (B)(6). PER EXEMPTION NUMBER E2016005, (B)(4). A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THE INVOLVED DEVICE HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP (B)(4) FOR 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 · 1

    SORIN GROUP (B)(4) HAS RECEIVED A REPORT THAT WATER WAS SEEN DROPPING FROM WATER COMPARTMENT DURING THE PRIMING OF THE BLOOD COMPARTMENT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452936 INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA SRL 1811130008

    Patients

    Seq Age Sex Outcome Treatment
    1