BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 8F

    MDR report key: 22736556 · Received August 7, 2025

    Report

    Report Number
    9680841-2025-900019
    Event Type
    Malfunction
    Date Received
    August 7, 2025
    Date of Event
    July 17, 2025
    Report Date
    August 7, 2025
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    UDI-DI
    000803622148255
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. NO PATIENT INFORMATION HAS BEEN PROVIDED. D.4. 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). G.5. THE INVOLVED INSPIRE 8M HOLLOW FIBER OXYGENATOR IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE STANDALONE OXYGENATOR (CATALOG NUMBER: 050703) IS ALSO REGISTERED IN THE USA (510(K) NUMBER: K180448). H.4. THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE OXYGENATOR WAS ASSEMBLED. H.11. LIVANOVA MANUFACTURES THE INSPIRE 8M HOLLOW FIBER OXYGENATOR. ACCORDING TO FOLLOW UP WITH THE CUSTOMER, THE BLOOD FLOW WAS APPROX. 4.5 LPM AND THE O2 SWEEP WAS ADJUSTED FROM 2.5 TO 5 LPM DURING THE CASE. 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 ITALIA RECEIVED A REPORT OF LOW PERFUSIONIST REPORTED NO VISIBLE BLOOD COLOR CHANGE IN LINES AFTER INITIATING BYPASS. INITIAL BYPASS STARTED AT 80% FIO2 DELIVERY AND NO BLOOD COLOR CHANGE OBSERVED. THE O2 DELIVERY INCREASED TO 100% AND STILL NO BLOOD COLOR CHANGE. THE GAS LINE TROUBLESHOOTING SHOWED APPROPRIATE GAS FLOW AND NO KINKS. THE ARTERIAL BLOOD GAS (ABG) DRAWN POST-OXYGENATOR SHOWED PAO2 OF 62MMHG AND VENOUS GAS SAMPLE DRAWN PRE-RESERVOIR SHOWED SVO2 OF 83 MMHG. THE PATIENT REMAINED HEMODYNAMICALLY STABLE WITH HEAD SATURATION NEARLY 70%. SPO2 FROM PATIENT WAS NOT AVAILABLE. MEDICAL TEAM ELECTED TO SWITCH TO E TANK AT 100% O2 AT 3 L/MIN SWEEP, REPEATED ABG POST OXYGENATOR AND PAO2 NOW WAS 56 MMHG. MEDICAL TEAM SWITCHED TO A 3RD GAS LINE FROM ANAESTHESIA SIDE OF CVOR, FIO2 WAS 100% O2 AT SWEEP 4 L/MIN SWEEP. THE PAO2 ON 3RD ARTERIAL BLOOD GAS POST OXYGENATOR REMAINED AT 65 MMHG WITH PERSISTENT DARK COLOUR OF BLOOD ON BOTH VENOUS AND ARTERIAL SIDES. MEDICAL TEAM ELECTED TO MAINTAIN SHORT THE BYPASS TIME. NO PATIENT INJURY REPORTED. POST-BYPASS ABG FROM PATIENT ON VENTILATOR (BY ANAESTHESIA) ON 100% FIO2 SHOWED PO2 OF 114MMHG. NO OTHER DETAILS PROVIDED. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2005806 INSPIRE 8F OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA INSPIRE 8F 2504080070 000803622148255

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown