BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR

    MDR report key: 6978989 · Received October 26, 2017

    Report

    Report Number
    9680841-2017-00028
    Event Type
    Malfunction
    Date Received
    October 26, 2017
    Date of Event
    September 27, 2017
    Report Date
    January 18, 2018
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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), MANUFACTURER (SORIN GROUP (B)(4)) REGISTRATION NUMBER: (B)(4). 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). 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.

    Description of Event or Problem · 0

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT PRIMING FLUID WAS OBSERVED LEAKING FROM THE BLOOD SIDE TO THE WATER SIDE OF THE INSPIRE 8F HOLLOW FIBER OXYGENATOR DURING PRIMING. THE CUSTOMER REPORTED THAT THE FLUID PASSED THROUGH WITH NO RESISTANCE. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    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). THE INVOLVED DEVICE WAS RETURNED TO SORIN GROUP (B)(4) FOR INVESTIGATION. THE UNIT WAS TESTED FOR LEAKAGE FROM THE BLOOD SIDE TO THE WATER SIDE OF THE HEAT EXCHANGER. NO LEAKS WERE OBSERVED DURING THIS TESTING. THE DEVICE WAS FOUND TO BE CONFORMING TO SPECIFICATIONS. AS THE ISSUE COULD NOT BE CONFIRMED, A ROOT CAUSE FOR THE REPORTED ISSUE WAS NOT IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, SORIN GROUP I(B)(4) HAS DETERMINED THAT THE REPORTED EVENT WAS NOT CAUSED BY A DEVICE MALFUNCTION, AS IT WAS FOUND TO BE CONFORMING TO SPECIFICATION DURING TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759953 INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA SRL 1705110224

    Patients

    Seq Age Sex Outcome Treatment
    1