BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 8 START P HOLLOW FIBER OXY W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES

    MDR report key: 5408880 · Received February 3, 2016

    Report

    Report Number
    9680841-2016-00019
    Event Type
    Malfunction
    Date Received
    February 3, 2016
    Date of Event
    January 8, 2016
    Report Date
    January 11, 2016
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT IS CURRENTLY STILL AT THE DECONTAMINATION FACILITY. THE PRODUCT ITEM 050712 IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO THE INSPIRE 8 OXYGENATOR 050714, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K130433). SORIN GROUP (B)(4) MANUFACTURES THE INSPIRE 8 START P 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 A SMALL LEAKAGE OF FOAM AND BLOOD WAS NOTED AT THE INSPIRE 8 START P GAS OUTLET PORT DURING A PROCEDURE. THE DEVICE WAS REPLACED IN ORDER TO CONTINUE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. THE INVESTIGATION IS ON GOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). SORIN GROUP (B)(4) MANUFACTURES THE INSPIRE 8 START P 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 A SMALL LEAKAGE OF FOAM AND BLOOD WAS NOTED AT THE INSPIRE 8 START P GAS OUTLET PORT DURING A PROCEDURE. THE DEVICE WAS REPLACED IN ORDER TO CONTINUE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. THIS EVENT WAS REPORTED TO THE COUNTRY'S LOCAL COMPETENT AUTHORITY. THIS MEDWATCH REPORT IS BEING FILED IN RESPONSE TO THIS ACTION. THE INVOLVED DEVICE WAS RETURNED TO SORIN GROUP (B)(4) FOR FURTHER INVESTIGATION. DURING LEAK TESTING, A LEAK BY THE EXTERNAL SURFACE OF THE FIBER BUNDLE WAS OBSERVED. MANUFACTURING RECORDS WERE REVIEWED AND THE OXYGENATOR WAS FOUND TO HAVE PASSED THE IN-PROCESS CONTROLS, INCLUDING A LEAK TEST, AND WAS RELEASED IN COMPLIANCE WITH PRODUCT SPECIFICATIONS. BECAUSE OF THIS, SORIN GROUP (B)(4) HAS CONCLUDED THAT THE ROOT CAUSE OF THE LEAK IS LIKELY DAMAGE TO THE OXYGENATOR FIBER CAUSED DUE TO THE THERMAL AND MECHANICAL STRESSES EXPERIENCED DURING STERILIZATION AND/OR SHIPPING. AS THE LEAK IS VERY SMALL, OVERSIGHT DURING THE IN-PROCESS LEAK TESTING COULD NOT BE EXCLUDED. THOUGH THE RATE OF OCCURRENCE FOR THIS TYPE OF ISSUE IS VERY LOW, SORIN GROUP (B)(4) PLANS TO INTRODUCE AN AUTOMATED VISION SYSTEM TO ENHANCE THE IN-PROCESS CONTROL OF THE INSPIRE OXYGENATOR FIBER INTEGRITY AND ELIMINATE ANY POSSIBILITY OF HUMAN ERROR DURING THE VISUAL IN-PROCESS CONTROL. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. SORIN GROUP (B)(4) WILL CONTINUE TO MONITOR FOR TRENDS RELATED TO THIS TYPE OF ISSUE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(6) RECEIVED A REPORT THAT A SMALL LEAKAGE OF FOAM AND BLOOD WAS NOTED AT THE INSPIRE 8 START P GAS OUTLET PORT DURING A PROCEDURE. THE DEVICE WAS REPLACED IN ORDER TO CONTINUE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66287 INSPIRE 8 START P HOLLOW FIBER OXY W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA N/A 1510190040

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR