BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CAR

    MDR report key: 8826994 · Received July 25, 2019

    Report

    Report Number
    9680841-2019-00031
    Event Type
    Malfunction
    Date Received
    July 25, 2019
    Date of Event
    June 26, 2019
    Report Date
    October 23, 2019
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Adverse Event
    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 6F M HOLLOW FIBER OXYGENATOR. THE INCIDENT OCCURRED IN (B)(4), BELGIUM. THE INVOLVED OXYGENATOR HAS BEEN RETURNED TO THE MANUFACTURER AND SUBMITTED TO GAMMA RAY DECONTAMINATION PRIOR THE INSPECTION. THE VISUAL INSPECTION FOUND NO DEFECTS NOR NON-CONFORMITIES. THE DEVICE WAS SUBMITTED TO TEST FOR TRANSMEMBRANE PRESSURE VERIFICATION: THE TEST COULD NOT REPRODUCE THE CLAIMED ISSUE, THE PRESSURE DROP VALUES MEASURED DURING OUR LABORATORY TEST WAS FOUND TO BE WITHIN PRODUCT SPECIFICATIONS AND THE DEVICE BEHAVED AS EXPECTED. 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 WERE NOT PROVIDED. THE INSPIRE 6F M HOLLOW FIBER OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK (ITEM IN00686, LOT 1904040045) 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. (B)(4). THE AGE OF THE DEVICE WAS CALCULATED AS THE TIME ELAPSED BETWEEN DEVICE STERILIZATION AND THE DATE OF EVENT. THE COMPLAINED INSPIRE 6F M HOLLOW FIBER OXYGENATOR IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE STANDALONE OXYGENATOR (CATALOG NUMBER 050702) IS REGISTERED IN THE USA (510(K) NUMBER: K130209). THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE OXYGENATOR WAS ASSEMBLED. SORIN GROUP ITALIA MANUFACTURES THE INSPIRE 6F M HOLLOW FIBER OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THE INVOLVED DEVICE HAS BEEN RECEIVED AT SORIN GROUP ITALIA FOR INVESTIGATION. 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

    LIVANOVA RECEIVED A REPORT THAT, DURING A CARDIOPULMONARY BYPASS, INCREASED TRANS-MEMBRANE OXYGENATOR PRESSURE WAS OBSERVED. THE MEDICAL TEAM ELECTED TO ADMINISTER NIPRIDE AND NITRIC OXIDE TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO ISSUE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621221 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CAR INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL DTZ SORIN GROUP ITALIA SRL 1904090012

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR