BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR

    MDR report key: 6408856 · Received March 16, 2017

    Report

    Report Number
    9680841-2017-00009
    Event Type
    Death
    Date Received
    March 16, 2017
    Date of Event
    February 16, 2017
    Report Date
    May 19, 2017
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    DTZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT IDENTIFIER WAS NOT PROVIDED. THE COMPLAINED INSPIRE 8M OXYGENATOR WAS A NON-STERILE COMPONENT ASSEMBLED INTO A STERILE CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT INTO WHICH THE OXYGENATOR WAS ASSEMBLED. AS THE STERILE FINISHED PRODUCT IS NOT DISTRIBUTED IN USA, THERE IS NO UNIQUE IDENTIFIER (UDI) NUMBER. HOWEVER, THE INVOLVED DEVICE IS SIMILAR TO INSPIRE 8M OXYGENATOR CATALOG NUMBER 050714, WHICH IS DISTRIBUTED IN THE USA, FOR WHICH THE DEVICE IDENTIFIER IS (B)(4). (B)(4). THE INSPIRE 8M OXYGENATOR WAS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE STAND ALONE OXYGENATOR (CATALOG NUMBER 050714) IS 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 8M HOLLOW FIBER OXYGENATOR. (B)(4). PER EXEMPTION NUMBER E2016005. 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.

    Additional Manufacturer Narrative · 0

    (B)(4) MANUFACTURES THE INSPIRE 8M HOLLOW FIBER OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). (B)(4). PER EXEMPTION NUMBER E2016005. THE INVOLVED DEVICE WAS RETURNED TO SORIN GROUP (B)(4) FOR INVESTIGATION. A THOROUGH INVESTIGATION OF THE RETURNED DEVICE WAS UNABLE TO REPLICATE THE REPORTED FAILURE. THE DEVICE PERFORMED AS EXPECTED, INCLUDING PRESSURE DROP. BASED ON THE INFORMATION PROVIDED, THE REPORTED INCREASE OF PRESSURE WAS ORIGINATED DOWNSTREAM FROM THE OXYGENATOR, WHICH WOULD MEAN THE DEVICE WAS NOT THE CAUSE. AS THE ISSUE WAS NOT REPRODUCED, A ROOT CAUSE WAS NOT DETERMINED.

    Description of Event or Problem · 0

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT A PATIENT ARRIVED AT THE OR FOR EMERGENCY SURGERY OF AORTA DISSECTION FOLLOWING CARDIAC ARREST. APPROXIMATELY 10 MINUTES AFTER INITIATING BYPASS, THE PRESSURE OF THE INSPIRE 8M OXYGENATOR RAPIDLY INCREASED AND LEAD TO A COMPLETE PUMP STOP. THE PATIENT WAS TAKEN OFF BYPASS AND SEVERAL MINUTES LATER, THE HEART STOPPED AND PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193478 INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA S.R.L. 1611100003

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death