BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 8 HOLLOW FIBER OXY. W/ INTEGRATED HARDSHELL VENOUS RESERVOIR

    MDR report key: 7137660 · Received December 21, 2017

    Report

    Report Number
    9680841-2017-00034
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Date of Event
    November 21, 2017
    Report Date
    February 27, 2018
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    DTZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SORIN GROUP (B)(4) MANUFACTURES THE INSPIRE 8M HOLLOW FIBER OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). PER EXEMPTION NUMBER E2016005, (B)(4). BOTH OXYGENATOR MODULES INVOLVED IN THE EVENT WERE RETURNED TOGETHER WITH THE WHOLE CIRCUIT TO SORIN GROUP (B)(4) FOR INVESTIGATION. HOWEVER, FIBER HYDROPHILIZATION AND MASSIVE CLOT PRESENCE DID NOT ALLOW EXECUTION OF ANY FUNCTIONAL TESTING. BASED ON THE INFORMATION PROVIDED, THE PROCEDURE WAS A REDO VALVE REPLACEMENT AND THE PATIENT WAS AFFECTED BY ENDOCARDITIS AND HEPARIN INDUCED THROMBOCYTOPENIA (HIT). MANAGEMENT OF ANTI-COAGULATION IN THE PRESENCE OF HIT CAN BE PROBLEMATIC AND THE APPLICATION OF HEPARIN IN THIS SPECIFIC CASE MAY HAVE CONTRIBUTED TO THE OBSERVED COAGULATION PHENOMENON. A PREEXISTING MEDICAL CONDITION AND/OR CLINICAL PRACTICE IS ONE POTENTIAL CAUSE OF THE REPORTED COAGULATION. THE CAUSE OF THE PATIENT DEATH WAS NOT REPORTED. AS AN INVESTIGATION COULD NOT BE PERFORMED, AN EXACT ROOT CAUSE WAS NOT DETERMINED.

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS NOT PROVIDED. DATE OF PATIENT DEATH WAS NOT PROVIDED. THE INSPIRE 8M HOLLOW FIBER OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK (LOT 1710050096) THAT IS NOT DISTRIBUTED IN THE USA. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT INTO WHICH THE OXYGENATOR WAS ASSEMBLED. THE CUSTOMER REPORTED TWO DEVICES INVOLVED IN THE EVENT. THE REPORTED LOT NUMBER REFERS TO THE NON-STERILE OXYGENATOR THAT WAS RETURNED TO SORIN GROUP (B)(4) FOR INVESTIGATION. 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 COMPLAINED INSPIRE 8M 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 050701) 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. THE INCIDENT OCCURRED IN (B)(6) . (B)(4). PER EXEMPTION NUMBER E2016005. REPORTEDLY, THE PATIENT WAS AFFECTED BY HEPARIN-INDUCED THROMBOCYTOPENIA, LEADING INVESTIGATORS TO BELIEVE A COAGULATION DISORDER WAS THE CAUSE OF THE EVENT. SORIN GROUP (B)(4) HAS REQUESTED ADDITIONAL INFORMATION TO EXCLUDE POTENTIAL RELATION BETWEEN THE DEVICE AND THE PATIENT DEATH. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THE INVOLVED DEVICE HAS BEEN RETURNED 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 CLOT FORMATION WAS OBSERVED IN THE RESERVOIR OF AN INSPIRE 8 HOLLOW FIBER OXYGENATOR DURING AN AORTIC VALVE REPLACEMENT PROCEDURE. THE OXYGENATOR WAS CHANGED OUT AND THE PATIENT WAS GIVEN AN ANTICOAGULANT (HEPARIN). HOWEVER, CLOTTING WAS ALSO OBSERVED IN THE SECOND OXYGENATOR AND THE PROCEDURE WAS TERMINATED. THE PATIENT WAS AFFECTED BY HEPARIN-INDUCED THROMBOCYTOPENIA AND REPORTEDLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920202 INSPIRE 8 HOLLOW FIBER OXY. W/ INTEGRATED HARDSHELL VENOUS RESERVOIR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA S.R.L. 1709120038

    Patients

    Seq Age Sex Outcome Treatment
    1 Death