BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR

    MDR report key: 5458214 · Received February 24, 2016

    Report

    Report Number
    9680841-2016-00057
    Event Type
    Injury
    Date Received
    February 24, 2016
    Date of Event
    January 27, 2016
    Report Date
    January 28, 2016
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.10: THE CORRECT EVENT DATE IS (B)(6) 2016, NOT (B)(6) 2016 AS INDICATED IN THE INITIAL REPORT. SECTION B.3 UPDATED ACCORDINGLY. AS PER E-MAIL FROM JALADHI, VIJAI D DATED 11 FEB 2021 LIVANOVA IS SUBMITTING THIS FOLLOW-UP IN REPLACEMENT OF THE ALREADY PROVIDED MEDWATCH 9680841-2016-00396 DUE TO THE FACT THAT THE REFERENCE PROVIDED WAS INCORRECT.

    Description of Event or Problem · 0

    SEE INITIAL SUBMITTED OUTSIDE OF RELIANCE (MFR 9680841-2016-00057).

    Additional Manufacturer Narrative · 1

    PMA 510(K): THE INSPIRE 8F M HOLLOW FIBER OXYGENATOR WAS ASSEMBLED INTO A CUSTOMIZED CIRCUIT, CODE IN00092, THAT IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO THE STERILE OXYGENATOR THAT IS DISTRIBUTED IN THE USA (510(K) NUMBER: K130433). SORIN GROUP (B)(4) MANUFACTURES THE INSPIRE 8M HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT, DURING BYPASS, A HIGH PREMEMBRANE PRESSURE WAS DETECTED FOR THE INSPIRE 8M OXYGENATOR. THE PERFUSIONIST ELECTED TO CONTINUE USING THE DEVICE AND TO COMPLETE THE PROCEDURE. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED BLINDNESS. IT WAS REPORTED ON (B)(6) 2016 THAT THE PATIENT IS SLOWLY RECOVERING VISION. A REVIEW OF THE DHR WAS UNABLE TO IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED FAILURE. THE INVESTIGATION IS ON GOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    MFR REPORT NUMBER: THE REPORT NUMBER INDICATED IN A PREVIOUSLY FILED FOLLOW-UP REPORT (FOLLOW-UP #1, FILED FEBRUARY 25, 2016) WAS INCORRECT. THE REPORT WAS FILED AS 9680841-2016-00396 FOLLOW-UP #1. THE CORRECT REPORT NUMBER IS 9680841-2016-00057. THIS REPORT AND ALL FUTURE REPORTS RELATING TO THIS COMPLAINT WILL CONTAIN REPORT NUMBER 9680841-2016-00057.

    Additional Manufacturer Narrative · 1

    (B)(4). SORIN GROUP (B)(4) MANUFACTURES THE INSPIRE 8M HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT, DURING BYPASS, A HIGH PREMEMBRANE PRESSURE WAS DETECTED FOR THE INSPIRE 8M OXYGENATOR. THE PERFUSIONIST ELECTED TO CONTINUE USING THE DEVICE AND TO COMPLETE THE PROCEDURE. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED BLINDNESS. IT WAS REPORTED ON FEBRUARY 9, 2016 THAT THE PATIENT BEGAN SLOWLY RECOVERING VISION. THE MANUFACTURING RECORD WAS REVIEWED AND THE OXYGENATOR WAS FOUND TO HAVE MET SPECIFICATIONS UPON RELEASE. THE INVOLVED OXYGENATOR WAS RETURNED TO SORIN GROUP (B)(4) FOR INVESTIGATION. VISUAL INSPECTION AND SEM ANALYSIS OF THE RETURNED DEVICE DID NOT IDENTIFY ANY RESIDUAL DRIED BLOOD IN THE OXYGENATOR OR HEAT EXCHANGER FIBER BUNDLES. VISUAL INSPECTION OF THE ARTERIAL FILTER IDENTIFIED RESIDUAL DRIED BLOOD. THE RESULTS OF AN SEM ANALYSIS INDICATES THAT THE DEPOSITS ARE COMPATIBLE WITH ACTIVATED PLATELET DEPOSITION. ANALYSIS OF THE PUMP RECORD WITH A PREDICTIVE MODEL CONFIRMED THAT A SIGNIFICANT INCREASE OF THE PREMEMBRANE PRESSURE OCCURRED 35 MINUTES AFTER THE PROCEDURE BEGAN. AS NO BLOOD RESIDUES WERE FOUND IN THE OXYGENATOR AND HEAT-EXCHANGER FIBER BUNDLE, SORIN GROUP (B)(4) IDENTIFIED THAT THE HIGH PRESSURE PHENOMENON WAS OF TRANSIENT TYPE. ALTHOUGH THE FREQUENCY OF THIS TYPE OF ISSUE IS LOW, SORIN GROUP (B)(4) HAS INITIATED A CAPA TO INVESTIGATE POSSIBLE TRIGGERING FACTORS.

    Description of Event or Problem · 1

    SORIN GROUP (B)(6) RECEIVED A REPORT THAT, DURING BYPASS, A HIGH PREMEMBRANE PRESSURE WAS DETECTED FOR THE INSPIRE 8M OXYGENATOR. THE PERFUSIONIST ELECTED TO CONTINUE USING THE DEVICE AND TO COMPLETE THE PROCEDURE. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED BLINDNESS. IT WAS REPORTED ON (B)(6) 2016 THAT THE PATIENT IS SLOWLY RECOVERING VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113139 INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA SRL N/A 1509070021

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Disability