BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 6 HOLLOW FIBER OXYGENATOR

    MDR report key: 13597892 · Received February 25, 2022

    Report

    Report Number
    9680841-2022-00011
    Event Type
    Malfunction
    Date Received
    February 25, 2022
    Date of Event
    January 27, 2022
    Report Date
    June 14, 2022
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WERE NOT PROVIDED. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT. THE COMPLAINED INSPIRE 6 OXYGENATOR (CATALOG NUMBER 050713J, LOT 2105240078) IS NOT DISTRIBUTED IN THE USA, THEREFORE THE UDI IS NOT APPLICABLE. THE OXYGENATOR ITEM 050713J IS SIMILAR TO THE INSPIRE 6 OXYGENATOR 050713, WHICH IS DISTRIBUTED IN THE USA, FOR WHICH THE DEVICE IDENTIFIER IS (B)(4). THE PRODUCT ITEM 050713J IS NOT DISTRIBUTED IN THE USA AND IT IS SIMILAR TO THE INSPIRE 6 OXYGENATOR CATALOGUE 050713, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K130209). THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED OXYGENATOR. SORIN GROUP (B)(4) MANUFACTURES THE INSPIRE 6 HOLLOW FIBER OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    LIVANOVA RECEIVED A REPORT ABOUT HIGH INLET PRESSURE DURING SURGERY. THE OXYGENATOR WAS REPLACED WITH ANOTHER ONE DURING HEARTH BEATING PHASE OF SURGERY AND CHANGE OUT TOOK 5-10 MINUTES. PATIENT/USER NOT AFFECTED. ANALYSIS OF THE PROVIDED PUMP SHEET CONFIRMED THE INCREASED TRANSMEMBRANE PRESSURE AFTER 24 MINUTES OF USAGE. THE INVOLVED OXYGENATOR WAS RETURNED TO LIVANOVA FOR TESTING. VISUAL INSPECTION FOUND CLOTTED BLOOD IN THE RETURNED OXYGENATOR. THE OXYGENATOR WAS EXTENSIVELY WASHED AND DRIED BEFORE LABORATORY TESTING. FUNCTIONAL TEST WITH BOVINE BLOOD CONFIRMED THE INCREASED TRANSMEMBRANE PRESSURE. VERIFICATION OF MANUFACTURING RECORDS CONFIRMED THAT CLAIMED DEVICE WAS RELEASED AS CONFORM ACCORDING TO SPECIFICATIONS. ANALYSIS OF LIVANOVA COMPLAINTS DATABASE REVEALED NO OTHER SIMILAR EVENT RELEVANT TO THE COMPLAINED LOT, THUS EXCLUDING A POSSIBLE QUALITY MANUFACTURING ISSUE. BASED ON INVESTIGATION RESULTS AND COLLECTED INFORMATION, MOST LIKELY ROOT CAUSE OF OCCURRED EVENT WAS ASSIGNED TO THE INCREASE OF HYDRAULIC RESISTANCE DUE TO UNDESIRED CELLULAR ACTIVATION INSIDE THE CIRCUIT ASSOCIATED WITH PLATELET ADHESION AND FIBRIN LAYER DEPOSITION WITHIN THE OXYGENATOR. THIS TYPE OF EVENT IS A MULTI-FACTORIAL PHENOMENON POSSIBLY TRIGGERED BY A COMBINATION OF CLINICAL PROCEDURE, THERAPIES (E.G. ANTICOAGULANT PRESCRIPTION, HEPARIN COMPOSITION AND PRIMING COMPOSITION) AND PATIENT-SPECIFIC HEALTH CONDITIONS. IN ADDITION, LABORATORY TEST COULD BE ALSO RELATED TO THE CONDITIONS OF RETURNED CLOGGED DEVICE WHICH PRESENTED BIOLOGICAL DEPOSITS WHICH REASONABLY REDUCED THE OPEN SURFACE FOR BLOOD FLOW, THIS RESULTING IN INCREASED PRESSURE DROP THROUGH THE UNIT. THE RISK IS IN THE ACCEPTABLE REGION. NO CORRECTIVE ACTION IS DEEMED NECESSARY.

    Description of Event or Problem · 0

    SORIN GROUP (B)(4) HAS RECEIVED A REPORT THAT, DURING A PROCEDURE, THE TRANSMEMBRANE PRESSURE OF THE INSPIRE 6 OXYGENATOR INCREASED UP TO 500MMHG. MEDICAL TEAM ELECTED TO CHANGE OUT THE OXYGENATOR. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Description of Event or Problem · 0

    SEE INITIAL REPORT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1333376 INSPIRE 6 HOLLOW FIBER OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA SRL 2105240078

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown