BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 8F HOLLOW FIBER OXY W/ INTEGRATED ARTERIAL FILTER AND HARDSHELL RES.

    MDR report key: 7856183 · Received September 7, 2018

    Report

    Report Number
    9680841-2018-00026
    Event Type
    Malfunction
    Date Received
    September 7, 2018
    Date of Event
    August 8, 2018
    Report Date
    October 19, 2018
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSPIRE 8F M HOLLOW FIBER OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK (LOT 1805030121) 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). THE INSPIRE 8F 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 050703) 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 8F M HOLLOW FIBER OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). PER EXEMPTION NUMBER E2016005. 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 OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    SORIN GROUP ITALIA MANUFACTURES THE INSPIRE 8F M HOLLOW FIBER OXYGENATOR. THE INCIDENT OCCURRED IN TORRETTE DI ANCONA, ITALY. PER EXEMPTION NUMBER E2016005, SORIN GROUP ITALIA S.R.L. IS SUBMITTING THE REPORT FOR BOTH SORIN GROUP ITALIA S.R.L (MANUFACTURER) AND LIVANOVA USA., INC. (IMPORTER). THE INVOLVED INSPIRE 8F OXYGENATOR WAS RETURNED TO SORIN GROUP ITALIA FOR INVESTIGATION. THE OXYGENATOR WAS SUBJECTED TO FUNCTIONAL TESTING WITH BOVINE BLOOD AND THE RESULTS OF THE GAS TRANSFER PERFORMANCE WERE FOUND TO BE IN LINE WITH PRODUCT SPECIFICATIONS. THE OXYGENATOR PERFORMED AS EXPECTED. A REVIEW OF THE DHR DID NOT REVEAL ANY RELEVANT INFORMATION POSSIBLY LINKED WITH THE CLAIMED DEFECT. THE COMPLAINED LOT HAS NOT BEEN REPORTED IN ANY OTHER COMPLAINT. AS NO PUMP-SHEET OF THE CASE WAS PROVIDED FOR ANALYSIS AND THE ISSUE COULD NOT BE REPRODUCED, A ROOT CAUSE COULD NOT BE DETERMINED AND CORRECTIVE ACTIONS WERE NOT IDENTIFIED.

    Description of Event or Problem · 0

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE COLOR OF THE BLOOD PASSING THROUGH THE INSPIRE 8F HOLLOW FIBER OXYGENATOR APPEARED DARK DURING A PROCEDURE. BLOOD ANALYSIS REPORTEDLY IDENTIFIED A BLOOD SATURATION OF 86% AND AN O2 PRESSURE OF 47MMHG. THE PERFUSIONIST INCREASED THE FIO2 AND REPEATED THE BLOOD ANALYSIS, HOWEVER THE VALUES DID NOT IMPROVE SIGNIFICANTLY. THE PROCEDURE WAS COMPLETED. THERE IS NO REPORT OF PATIENT INJURY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698945 INSPIRE 8F HOLLOW FIBER OXY W/ INTEGRATED ARTERIAL FILTER AND HARDSHELL RES. OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA SRL 1805110052

    Patients

    Seq Age Sex Outcome Treatment
    1