BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL

    MDR report key: 5349524 · Received January 7, 2016

    Report

    Report Number
    9680841-2015-00640
    Event Type
    Malfunction
    Date Received
    January 7, 2016
    Date of Event
    July 8, 2015
    Report Date
    December 8, 2015
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PMA 510(K). THE INSPIRE 6F M WAS ASSEMBLED INTO A CUSTOMIZED CIRCUIT (ITEM IN00219) THAT IS NOT DISTRIBUTED IN THE USA, BUT THE OXYGENATOR IS SIMILAR TO THE INSPIRE 6F M THAT IS DISTRIBUTED IN THE USA (510K#: K120185). SORIN GROUP (B)(4) MANUFACTURES THE INSPIRE 6F M OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP. SORIN GROUP (B)(4) RECEIVED A REPORT OF HIGH PRESSURE AT THE BEGINNING OF A PROCEDURE USING THE INSPIRE 6F M HOLLOW FIBER OXYGENATOR. THE OXYGENATOR WAS CHANGED OUT AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF PATIENT INJURY. THE EVENT WAS REPORTED TO THE COUNTRY'S LOCAL COMPETENT AUTHORITY. THIS MEDWATCH REPORT IS BEING FILED IN RESPONSE TO THIS ACTION. THE INVOLVED OXYGENATOR WAS RETURNED TO SORIN GROUP (B)(4) FOR FURTHER INVESTIGATION. THE MANUFACTURING RECORD WAS REVIEWED AND THE OXYGENATOR WAS FOUND TO MEET THE SPECIFICATIONS. THE ANALYSIS OF THE PUMP RECORD CONFIRMED THAT THE INLET PRESSURE STEADILY INCREASED AT THE BEGINNING OF THE PROCEDURE, HOWEVER THE INVESTIGATION PERFORMED BY SORIN FOUND NO EVIDENCE THAT COULD RELATE THE REPORTED ISSUE TO THE OXYGENATOR. A CAPA HAS BEEN INITIATED TO INVESTIGATE THIS TYPE OF ISSUE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT OF HIGH PRESSURE AT THE BEGINNING OF A PROCEDURE USING THE INSPIRE 6F M HOLLOW FIBER OXYGENATOR. THE OXYGENATOR WAS CHANGED OUT AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9408 INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA NA 1505200031

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR