BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 5707764 · Received June 8, 2016

    Report

    Report Number
    9680841-2016-00376
    Event Type
    Injury
    Date Received
    June 8, 2016
    Date of Event
    May 6, 2016
    Report Date
    May 9, 2016
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION WERE PROVIDED. THE UNIT HAS NOT YET BEEN RETURNED TO SORIN GROUP (B)(4). THE INSPIRE 6F M WAS ASSEMBLED INTO A CUSTOMIZED CIRCUIT (ITEM (B)(4)) 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 8 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 TWO MINUTES AFTER THE START OF THE CEC PROCEDURE, THERE WAS A SUDDEN INCREASE OF THE PREMEMBRANE PRESSURE OF THE INSPIRE 6F M OXYGENATOR, FOLLOWED BE A SIGNIFICANT BLOOD LEAK FROM THE OXYGENATOR INLET, RESULTING IN THE LOSS OF ABOUT 4L OF BLOOD. THE USER ATTEMPTED TO RECONNECT THE TUBE ONTO THE OXYGENATOR INLET CONNECTOR, BUT WAS UNSUCCESSFUL. THE PROCEDURE WAS STOPPED IN ORDER TO REPLACE THE OXYGENATOR. THE PATIENT WAS INFUSED WITH 8 BLOOD BAGS WHICH LED TO TRANSFUSION-RELATED ACUTE LUNG INJURY (TRALI). THE PATIENT IS AWAKE BUT HAS NOT BEEN DISCHARGED FROM THE HOSPITAL. THE OXYGENATOR AND TUBING ARE DELIVERED TO THE CUSTOMER AS SEPARATE PARTS, AND THE CONNECTION BETWEEN THE OXYGENATOR INLET AND THE CORRESPONDING TUBING IS MADE BY CLINICAL PERSONAL. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. 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 THE INSPIRE 8 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 TWO MINUTES AFTER THE START OF THE CEC PROCEDURE, THERE WAS A SUDDEN INCREASE OF THE PREMEMBRANE PRESSURE OF THE INSPIRE 6F M OXYGENATOR, FOLLOWED BE A SIGNIFICANT BLOOD LEAK FROM THE OXYGENATOR INLET, RESULTING IN THE LOSS OF ABOUT 4L OF BLOOD. THE USER ATTEMPTED TO RECONNECT THE TUBE ONTO THE OXYGENATOR INLET CONNECTOR, BUT WAS UNSUCCESSFUL. THE PROCEDURE WAS STOPPED IN ORDER TO REPLACE THE OXYGENATOR. THE PATIENT WAS INFUSED WITH 8 BLOOD BAGS WHICH LED TO TRANSFUSION-RELATED ACUTE LUNG INJURY (TRALI). THE CURRENT PATIENT STATUS IS UNKNOWN. THE OXYGENATOR AND TUBING ARE DELIVERED TO THE CUSTOMER AS SEPARATE PARTS, AND THE CONNECTION BETWEEN THE OXYGENATOR INLET AND THE CORRESPONDING TUBING IS MADE BY CLINICAL PERSONAL. DESPITE SEVERAL ATTEMPTS MADE BY SORIN GROUP (B)(4) TO RETRIEVE INFORMATION REGARDING THE PATIENT STATUS AND TO HAVE THE INVOLVED UNIT RETURNED FOR INVESTIGATION, THE HOSPITAL HAS NOT DISCLOSED ANY NEW INFORMATION, NOR PROVIDED THE DEVICE FOR INVESTIGATION. WITHOUT THE ABILITY TO INVESTIGATE THE UNIT, SORIN GROUP (B)(4) CANNOT DETERMINE A ROOT CAUSE OR IDENTIFY CORRECTIVE ACTIONS. SUCH A CONNECTION WAS PERFORMED BY THE CLINICAL PERSONAL AND IT CANNOT BE EXCLUDED THAT THE TUBING WAS INCORRECTLY FIT ONTO THE BLOOD-INLET CONNECTOR. 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)(4) RECEIVED A REPORT THAT TWO MINUTES AFTER THE START OF THE CEC PROCEDURE, THERE WAS A SUDDEN INCREASE OF THE PREMEMBRANE PRESSURE OF THE INSPIRE 6F M OXYGENATOR, FOLLOWED BE A SIGNIFICANT BLOOD LEAK FROM THE OXYGENATOR INLET, RESULTING IN THE LOSS OF ABOUT 4L OF BLOOD. THE USER ATTEMPTED TO RECONNECT THE TUBE ONTO THE OXYGENATOR INLET CONNECTOR, BUT WAS UNSUCCESSFUL. THE PROCEDURE WAS STOPPED IN ORDER TO REPLACE THE OXYGENATOR. THE PATIENT WAS INFUSED WITH 8 BLOOD BAGS WHICH LED TO TRANSFUSION-RELATED ACUTE LUNG INJURY (TRALI). THE PATIENT IS AWAKE BUT HAS NOT BEEN DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361920 INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA 1510230018

    Patients

    Seq Age Sex Outcome Treatment
    1 Other