BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 8 HOLLOW FIBER OXY. W/ INTEGRATED HARDSHELL VENOUS CARDIOTOTOMY RESERV

    MDR report key: 7108198 · Received December 12, 2017

    Report

    Report Number
    9680841-2017-00032
    Event Type
    Malfunction
    Date Received
    December 12, 2017
    Date of Event
    November 13, 2017
    Report Date
    March 7, 2018
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SORIN GROUP (B)(4) MANUFACTURES THE INSPIRE 8M HOLLOW FIBER OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). PER EXEMPTION NUMBER E2016005, (B)(4). THE INVOLVED DEVICE WAS RETURNED TO SORIN GROUP (B)(4) FOR INVESTIGATION. DURING VISUAL INSPECTION, IT WAS DISCOVERED THAT THE REPORTED EVENT WAS CAUSED BY AN ISSUE WITH THE OXYGENATOR PURGE LINE. THE PURGE LINE IS NOT PART OF THE INSPIRE 8M OXYGENATOR, BUT IT IS ASSEMBLED AND PLACED INTO THE SAME CUSTOM PACK AS THE INSPIRE BY LIVANOVA USA. NO DEVICE FAILURE WAS FOUND FOR THE INSPIRE 8M OXYGENATOR. BECAUSE THE ISSUE WAS NOT RELATED TO A PRODUCT MANUFACTURED BY SORIN GROUP (B)(4), THIS MEDWATCH REPORT IS VOID. A NEW MEDWATCH REPORT WILL BE SUBMITTED BY THE MANUFACTURER OF THE PURGE LINE (LIVANOVA USA) TO ADDRESS THE IDENTIFIED ISSUE.

    Additional Manufacturer Narrative · 0

    THE INSPIRE 8M HOLLOW FIBER OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT INTO WHICH THE OXYGENATOR WAS ASSEMBLED. THE UNIQUE IDENTIFIER (UDI) NUMBER OF THE STERILE CONVENIENCE PACK IS (B)(4). THE AGE OF THE DEVICE WAS CALCULATED AS THE TIME ELAPSED BETWEEN DEVICE STERILIZATION AND THE DATE OF EVENT. (B)(4). THE COMPLAINED INSPIRE 8M HOLLOW FIBER OXYGENATOR IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE STAND ALONE OXYGENATOR (CATALOG NUMBER 050701) IS ALSO REGISTERED IN THE USA (510(K) NUMBER: K130433). THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE OXYGENATOR WAS ASSEMBLED. SORIN GROUP (B)(4) MANUFACTURES THE INSPIRE 8M HOLLOW FIBER OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). PER EXEMPTION NUMBER E2016005, (B)(4) A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THE INVOLVED DEVICE HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP (B)(4) FOR INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE RECIRCULATION LINE OF INSPIRE 8 M WAS FOUND LEAKING DURING PRIMING. USER TIGHTENED THE CONNECTION OF THE LINE TO THE OXYGENATOR AND WENT ON BYPASS. DESPITE SEVERAL ATTEMPTS TO TIGHTEN THE LINE THE LEAK WAS OBSERVED AGAIN ON BYPASS. THE OXYGENATOR WAS CHANGED OUT. THE PATIENT RECIEVED 4 UNITS OF BLOOD.THERE WAS NON REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889375 INSPIRE 8 HOLLOW FIBER OXY. W/ INTEGRATED HARDSHELL VENOUS CARDIOTOTOMY RESERV OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA 1706070140

    Patients

    Seq Age Sex Outcome Treatment
    1