BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 6F HOLLOW FIBER OXY W/ INTEGRATED ARTERIAL FILTER & HARDSHELL RES

    MDR report key: 7649617 · Received June 29, 2018

    Report

    Report Number
    9680841-2018-00017
    Event Type
    Malfunction
    Date Received
    June 29, 2018
    Date of Event
    June 6, 2018
    Report Date
    August 27, 2018
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT IDENTIFIER, AGE AND SEX WERE NOT PROVIDED. THE INSPIRE 6F M HOLLOW FIBER OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK (LOT 1801230134) 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 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 STAND ALONE 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. THE INVOLVED DEVICE WAS RETURNED TO SORIN GROUP (B)(4) ON JUNE 15, 2018 AND HAS BEEN SENT TO AN EXTERNAL SUPPLIER FOR DECONTAMINATION. SORIN GROUP (B)(4) MANUFACTURES THE INSPIRE 6F M HOLLOW FIBER OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). PER EXEMPTION NUMBER E2016005. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE UNDERGOING DECONTAMINATION.

    Additional Manufacturer Narrative · 0

    SORIN GROUP ITALIA MANUFACTURES THE INSPIRE 6F M HOLLOW FIBER OXYGENATOR. THE INCIDENT OCCURRED IN MANCHESTER, UNITED KINGDOM. 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 DEVICE WAS RETURNED TO SORIN GROUP ITALIA FOR EVALUATION. VISUAL INSPECTION IDENTIFIED NO DEFECTS OR NON-CONFORMITIES. BIOLOGICAL TRACES MAINLY COMPOSED OF RED DEPOSITS WERE VISIBLE. THESE WERE LIKELY DUE TO FIBRIN DEPOSITION AND EMBEDDED RED BLOOD CELLS. THE DEVICE WAS EXTENSIVELY RINSED, HOWEVER IT WAS NOT POSSIBLE TO REMOVE ALL BIOLOGICAL TRACES. THEREFORE, IT WAS NOT POSSIBLE TO SUBMIT THE DEVICE TO TRANSMEMBRANE PRESSURE VERIFICATION AS THE FLOWING OF WATER THROUGH THE DEVICE WAS IMPAIRED BY THE BIOLOGICAL DEPOSITS. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. BASED ON THE EVIDENCE OF DEVICE INSPECTION AND ON PREVIOUSLY INVESTIGATED SIMILAR CASES, SORIN GROUP ITALIA BELIEVES A LIKELY ROOT CAUSE OF THE INCREASED PRESSURE DROP TO BE PLATELET ADHESION AND FIBRIN LAYER DEPOSITION INSIDE THE OXYGENATOR. THE MOST PROBABLE ROOT CAUSE OF PLATELET ADHESION AND FIBRIN DEPOSITION IS MULTI-FACTORIAL AND INCLUDES THE CLINICAL PROCEDURE (E.G SURGICAL MATERIAL), THERAPIES (E.G. ANTICOAGULANT PRESCRIPTION, HEPARIN COMPOSITION AND PRIMING COMPOSITION) AND PATIENT SPECIFIC HEALTH CONDITIONS. THE EVENT DOES NOT APPEAR TO BE DEVICE-SPECIFIC.

    Description of Event or Problem · 0

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT WHEN A PROCEDURE WAS RESTARTED FOLLOWING 70 MINUTES OF BYPASS, THE BLOOD FLOW WOULD NOT GO ABOVE 2.9 LPM DESPITE THE REVOLUTION PUMP SET TO MAXIMUM, AND THE ARTERIAL BLOOD WAS BLACK. THE MEDICAL TEAM ELECTED TO VENTILATE THE PATIENT, STOP THE BYPASS AND CHANGE-OUT THE INSPIRE 6F HOLLOW FIBER OXYGENATOR. FOLLOWING THE CHANGE-OUT, 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
    493270 INSPIRE 6F HOLLOW FIBER OXY W/ INTEGRATED ARTERIAL FILTER & HARDSHELL RES OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA 1801250177

    Patients

    Seq Age Sex Outcome Treatment
    1