BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER HARDSHELL VENOUS/CARDIO

    MDR report key: 5370991 · Received January 15, 2016

    Report

    Report Number
    9680841-2015-00656
    Event Type
    Malfunction
    Date Received
    January 15, 2016
    Date of Event
    December 7, 2015
    Report Date
    December 18, 2015
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 THE PROCEDURE THE INSPIRE 8F M HOLLOW FIBER OXYGENATOR HAD A SLOW LEAK COMING FROM THE OXYGENATOR GAS EXHAUST PORT. NO LEAK HAD BEEN DETECTED DURING PRIME. THE CLINICIAN ELECTED TO CONTINUE USING THE DEVICE AND COMPLETED THE PROCEDURE. BLOOD LOSS WAS APPROXIMATELY 10CC. 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 DEVICE WAS RETURNED TO SORIN GROUP (B)(4) FOR FURTHER INVESTIGATION. THE DEVICE WAS FILLED WITH DYE AND PRESSURIZED TO 1 BAR AND A LEAK WAS IDENTIFIED COMING FROM THE FIBER BUNDLE. SUBSEQUENT AUTOPSY OF THE RETURNED OXYGENATOR CONFIRMED THAT THE ORIGIN OF THE LEAK WAS A DAMAGED CAPILLARY OF THE OXY MODULE FIBER BUNDLE. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THE UNIT PASSED THE IN-PROCESS CONTROLS, INCLUDING A LEAK TEST, AND WAS RELEASED IN COMPLIANCE WITH PRODUCT SPECIFICATIONS. SORIN GROUP (B)(4) HAS CONCLUDED THAT THE MOST LIKELY CAUSE OF THE LEAK WAS FIBER DAMAGE THAT WAS EXACERBATED DUE TO THERMAL AND MECHANICAL STRESSES INDUCED DURING STERILIZATION, TRANSPORT AND USE. SORIN GROUP (B)(4) PLANS TO INTRODUCE AN AUTOMATED VISION SYSTEM TO ENHANCE THE IN-PROCESS CONTROL OF INSPIRE OXYGENATOR FIBER INTEGRITY AND ELIMINATE ANY POSSIBILITY OF HUMAN ERROR DURING VISUAL IN PROCESS CONTROL.

    Additional Manufacturer Narrative · 1

    THE INSPIRE 8F M HOLLOW FIBER OXYGENATOR WAS ASSEMBLED INTO A CUSTOMIZED HEART LUNG PACK THAT IS NOT DISTRIBUTED IN THE USA. THE STERILE INSPIRE OXYGENATOR IS DISTRIBUTED IN THE USA AND THE 510K NUMBER IS K130433. AT THE DATE OF THE PRESENT REPORT, THE UNIT HAS NOT BEEN RETURNED TO THE MANUFACTURER FACILITIES FOR INVESTIGATION. 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 THE PROCEDURE THE INSPIRE 8F M HOLLOW FIBER OXYGENATOR HAD A SLOW LEAK COMING FROM THE OXYGENATOR GAS EXHAUST PORT. NO LEAK HAD BEEN DETECTED DURING PRIME. THE CLINICIAN ELECTED TO CONTINUE USING THE DEVICE AND COMPLETED THE PROCEDURE. BLOOD LOSS WAS APPROXIMATELY 10CC. 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 INVESTIGATION IS ON GOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT DURING THE PROCEDURE THE INSPIRE 8F M HOLLOW FIBER OXYGENATOR HAD A SLOW LEAK COMING FROM THE OXYGENATOR GAS EXHAUST PORT. NO LEAK HAD BEEN DETECTED DURING PRIME. THE CLINICIAN ELECTED TO CONTINUE USING THE DEVICE AND COMPLETED THE PROCEDURE. BLOOD LOSS WAS APPROXIMATELY 10CC. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30391 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER HARDSHELL VENOUS/CARDIO OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA NA 1510300075

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR