BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 8F HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VEN/CARDIOTOMY RESERV

    MDR report key: 6043423 · Received October 20, 2016

    Report

    Report Number
    9680841-2016-00508
    Event Type
    Malfunction
    Date Received
    October 20, 2016
    Date of Event
    September 19, 2016
    Report Date
    September 23, 2016
    Manufacturer
    SORIN GROUP ITALI SRL
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINED INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS CARDIOTOMY RESERVOIR WAS A NON-STERILE COMPONENT ASSEMBLED INTO A STERILE CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE CATALOG NUMBER, LOT NUMBER, AND EXPIRATION DATE REFER TO THE STERILE FINISHED PRODUCT INTO WHICH THE OXYGENATOR WAS ASSEMBLED. AS THE STERILE FINISHED PRODUCT IS NOT DISTRIBUTED IN USA, THERE IS NO UNIQUE IDENTIFIER (UDI) NUMBER. HOWEVER, THE INSPIRE 8F IS SIMILAR TO THE INSPIRE 8F OXYGENATOR 050716, WHICH IS DISTRIBUTED IN THE USA, FOR WHICH THE DEVICE IDENTIFIER IS (B)(4). (B)(6). THE INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS CARDIOTOMY RESERVOIR WAS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE STAND ALONE OXYGENATOR IS REGISTERED IN THE USA (510(K) NUMBER: K130433). SORIN GROUP (B)(4) MANUFACTURES INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS CARDIOTOMY RESERVOIR. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT A BLOOD LEAK FROM THE BOTTOM OF THE INSPIRE 8F OXYGENATOR WAS OBSERVED 60 MINUTES INTO BYPASS. THE MEDICAL TEAM ELECTED TO USE THE DEVICE TO COMPLETE THE PROCEDURE. THE WAS NO REPORT OF PATIENT INJURY. ON SEPTEMBER 23, 2016, SORIN GROUP (B)(4) WAS NOTIFIED THAT THE USER FACILITY HAD SUBMITTED A REPORT TO THE LOCAL COMPETENT AUTHORITY. THIS MEDWATCH REPORT IS BEING FILED IN RESPONSE TO THIS ACTION. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THE DEVICE WAS RETURNED TO SORIN GROUP (B)(4) FOR INVESTIGATION AND HAS BEEN SENT FOR DECONTAMINATION. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION WILL BE COMPLETED.

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS CARDIOTOMY RESERVOIR. THE INCIDENT OCCURRED IN (B)(6). THE OXYGENATOR WAS RETURNED TO SORIN GROUP (B)(4) FOR FURTHER INVESTIGATION. THE DEVICE WAS LEAK TESTED WITH A BLUE DYE SOLUTION, WHICH CONFIRMED THE PRESENCE OF A DAMAGED FIBER THAT RESULTED IN A LEAK IN THE GAS COMPARTMENT OF THE OXYGENATOR. THE DAMAGED FIBER WAS LOCATED IN THE CENTRAL PART OF OXYGENATOR FIBER BUNDLE. BASED ON THE REVIEW OF THE DHR, THE COMPLAINED OXYGENATOR SUCCESSFULLY PASSED THE IN-PROCESS LEAK TEST. SORIN GROUP (B)(4) IDENTIFIED THE MOST PROBABLE CAUSE OF THE LEAK TO BE A DAMAGED FIBER THAT PASSED THE IN PROCESS LEAK TEST BUT WAS FURTHER DAMAGED THROUGH THERMAL AND MECHANICAL STRESS DURING STERILIZATION, TRANSPORT AND USE. HUMAN ERROR DURING THE IN-PROCESS LEAK TESTING CANNOT BE EXCLUDED AS ANOTHER POSSIBILITY. DESPITE THE LOW FREQUENCY AND RISK LEVEL FOR THIS TYPE OF EVENT, AN AUTOMATED VISION SYSTEM FOR IN-PROCESS CONTROL OF THE INSPIRE OXYGENATOR FIBER INTEGRITY IS BEING INTRODUCED TO ELIMINATE POTENTIAL HUMAN ERROR.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT A BLOOD LEAK FROM THE BOTTOM OF THE INSPIRE 8F OXYGENATOR WAS OBSERVED 60 MINUTES INTO BYPASS. THE MEDICAL TEAM ELECTED TO USE THE DEVICE TO COMPLETE THE PROCEDURE. THE WAS NO REPORT OF PATIENT INJURY. ON SEPTEMBER 23, 2016, SORIN GROUP (B)(4) WAS NOTIFIED THAT THE USER FACILITY HAD SUBMITTED A REPORT TO THE LOCAL COMPETENT AUTHORITY. THIS MEDWATCH REPORT IS BEING FILED IN RESPONSE TO THIS ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694306 INSPIRE 8F HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VEN/CARDIOTOMY RESERV OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALI SRL 1602120073

    Patients

    Seq Age Sex Outcome Treatment
    1