BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 7M HOLLOW FIBER OXYGENATOR, INSPIRE 7 DUAL HOLLOW FIBER OXYGENATOR

    MDR report key: 8713387 · Received June 19, 2019

    Report

    Report Number
    9680841-2019-00024
    Event Type
    Malfunction
    Date Received
    June 19, 2019
    Date of Event
    May 21, 2019
    Report Date
    May 21, 2019
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SORIN GROUP ITALIA MANUFACTURES THE INSPIRE 7 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL. THE INCIDENT OCCURRED IN (B)(6), BELGIUM THE INVOLVED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER. VISUAL INSPECTION COULD NOT IDENTIFY ANY STRUCTURAL DEFECT NEITHER ANY RESIDUAL BLOOD TRACES. TO INVESTIGATE THE PRESENCE OF POSSIBLE BIOLOGICAL TRACES, RELATED TO THE CLAIMED FAILURE, THE DEVICE WAS SECTIONED. TRACES OF BIOLOGICAL DEPOSITS WERE IDENTIFIED WITHIN THE OXYGENATOR AND HEAT EXCHANGER FIBER BUNDLE. NO MATERIAL STRUCTURAL NON-CONFORMITY WAS IDENTIFIED. AS PER THE EVIDENCES COLLECTED, THE ROOT CAUSE OF THE EVENT COULD NOT BE TRACED TO ANY DEVICE-RELATED MALFUNCTION SINCE THE INCREASE OF HYDRAULIC RESISTANCE EXPERIENCED BY CUSTOMER IS RELATED TO UNDESIRED CELLULAR ACTIVATION ASSOCIATED WITH PLATELET ADHESION AND FIBRIN LAYER DEPOSITION INSIDE THE OXYGENATOR. BASED ON MEDICAL LITERATURE, THE ORIGIN OF THE ACTIVATION AND INTERACTION APPEARS TO BE NOT DEVICE RELATED AND TO BE MULTI-FACTORIAL. FOR THIS REASON, NO SPECIFIC CORRECTIVE ACTION HAS BEEN IDENTIFIED AT THE PRESENT DATE. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED. THE INSPIRE 7 M HOLLOW FIBER OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK (LOT 1904020116) 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 CONVENIENCE PACK IS NOT DISTRIBUTED IN USA, THE UDI NUMBER IS NOT APPLICABLE. 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 COMPLAINED INSPIRE 7 M HOLLOW FIBER OXYGENATOR IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE STAND ALONE OXYGENATOR (CATALOG NUMBER 050725) IS REGISTERED IN THE USA (510(K) NUMBER: K190690). 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 7 M HOLLOW FIBER OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). PER EXEMPTION NUMBER E2016005, SORIN (B)(4) . IS SUBMITTING THE REPORT FOR BOTH SORIN GROUP (B)(4) (MANUFACTURER) AND LIVANOVA USA., INC. (IMPORTER). A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THE OXYGENATOR HAS BEEN RECEIVED AT SORIN (B)(4) FACILITIES. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    SORIN GROUP (B)(6) HAS BEEN INFORMED THAT OF A CASE OF INCREASED OXYGENATOR TRANSMEMBRANE PRESSURE DURING A PROCEDURE. THE MEDICAL TEAM ELECTED TO ADMINISTER SODIUM NITROPRUSSIDE TO THE PATIENT. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504174 INSPIRE 7M HOLLOW FIBER OXYGENATOR, INSPIRE 7 DUAL HOLLOW FIBER OXYGENATOR INSPIRE 7 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL/VENOUS CARDIOTOMY RE DTZ SORIN GROUP ITALIA SRL 1903150158

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR