BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 7F

    MDR report key: 21310884 · Received February 5, 2025

    Report

    Report Number
    9680841-2025-00005
    Event Type
    Malfunction
    Date Received
    February 5, 2025
    Date of Event
    January 6, 2025
    Report Date
    September 25, 2025
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. NO PATIENT INFORMATION HAS BEEN PROVIDED. D.4. THE INSPIRE 7F OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA (ITEM 044059102 LOT 2430900036). THE EXP DATE REFERS TO THE STERILE CONVENIENCE PACK. THE UNIQUE IDENTIFIER (UDI) NUMBER IS (B)(4). G.5. THE INVOLVED INSPIRE 7F OXYGENATOR IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE STANDALONE OXYGENATOR (CATALOG NUMBER 050729) IS ALSO REGISTERED IN THE USA (510(K) NUMBER: K200683). H.4. THE INSPIRE 7F OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE MFG DATE REFERS TO THE STERILE CONVENIENCE PACK. H.11. LIVANOVA MANUFACTURES THE INSPIRE 7F OXYGENATOR. THE INVOLVED DEVICE HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP ITALIA FOR INVESTIGATION. THE X-CLAMP WAS APPLIED AND DURING INDUCTION OF DEL NIDO, THE ARTERIAL PRESSURE EXCEEDED 350 MMHG PRESSURE LIMIT ON THE PUMP IS SET TO 350 MMHG AND THE CENTRIFUGAL PUMP RAMPED DOWN TO THE LOW RPM SETTING OF 1500 RPMS THE EQUIPMENT WORKED AS INTENDED REDUCING THE RPMS OF THE CENTRIFUGAL PUMP BUT WHEN THE PRESSURE SPIKED SETTING OFF THE PRESSURE ALARM, THE ARTERIAL FLOW HAD STOPPED. THEY DO NOT UTILIZE AN ARTERIAL CLAMP NO FLOW WAS BEING DISPLAYED FROM THE ARTERIAL FLOW SENSOR. THE PERFUSION VERIFIED NO KINKING OF THE ARTERIAL LINE, CENTRIFUGAL PUMP WAS SPINNING, NO FLOW THROUGH THE RECIRCULATION LINE, NO FLOW NO FLOW THROUGH THE AV BRIDGE AND THE SURGEON DECANNULATED AND VERIFIED NO FLOW THROUGH THE ARTERIAL LINE. THE SURGEON EVEN DE-CANNULATED BY PULLING THE ARTERIAL LINE OFF THE CANNULA BUT NO BLOOD FLOW TO THE FIELD COULD BE OBTAINED. MEDICAL TEAM CHANGED THE HLM, CIRCUIT AND OXYGENATOR: OFF BYPASS FOR 8 MINUTES WITH AN ARRESTED HEART DURING THE X-CLAMP APPLICATION. ALL OF THE BLOOD IN THE FIRST CIRCUIT WAS GIVEN BACK TO THE NEW CIRCUIT. THEY WERE ACTIVELY COOLING AT THE TIME OF THE FLOW STOPPED. BLADDER TEMP WAS 34C AND THE ARTERIAL BLOOD TEMP WAS 29C. THE PATIENT IS IN GOOD CONDITION IN THE ICU POST-SURGERY. IT IS UNCLEAR WHETHER THE FLOW ACTUALLY STOPPED OR DECREASED ONLY. THE DISCONNECTION OF THE ARTERIAL LINE FROM THE CANNULA PERFORMED BY THE MEDICAL TEAM DURING THE CASE SHALL BE CONSIDERED SOLELY A TROUBLESHOOTING PRACTICE THE SUDDEN BLOCKAGE OF THE BLOOD FLOW IN BYPASS RESULTING FROM A MAJOR CLOTTING OF THE OXYGENATOR TYPICALLY OCCURS DURING THE COOLING PHASE (WHICH IS THE CASE) AND CAN BE DUE TO SPECIFIC ANTIBODIES (COLD AGGLUTININS) THAT BIND TO THE SURFACE OF RBCS AND PROVOKE AGGREGATION OF BLOOD CELLS WHEN THE BLOOD IS COOLED. THE CHANGE OUT OF THE CIRCUIT THAT WAS CONDUCTED BY THE MEDICAL TEAM REDUCES THE RISK OF THIS COLD BLOOD-REACTION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    H11: INVOLVED OXYGENATOR RETURNED FOR INVESTIGATION. THE DEVICE WAS FOUND CLEAN AND EMPTY WHEN VISUALLY INSPECTED, WITH NO VISIBLE TRACES OF BLOOD ALONG THE OXYGENATOR FIBERS. A FUNCTIONAL TEST WITH BOVINE BLOOD WAS RUN ON THE RETURNED SAMPLE. LABORATORY TEST COULD NOT REPRODUCE ANY INCREASED PRESSURE DROP ACROSS THE OXYGENATOR WHICH BEHAVED AS EXPECTED, WITHOUT ANY PERFORMANCE DEVIATION IDENTIFIED IN TERMS OF PRESSURE EXCURSION IN THE BLOOD PATH. MEASURED P IN THE BLOOD PATH (161 MMHG @6 LPM) WAS FOUND ALIGNED WITH THE ACCEPTABLE RANGE OF VALUES PRESCRIBED WITHIN THE PRODUCT SPECIFICATIONS, AS PER THE REPORTED BLOOD PARAMETERS TEST CONDITIONS (P = 120-230 MMHG @6 LPM BLOOD FLOW-RATE WITH HB=12 ± 1 G/DL, AND T=37 ± 1°C). TAKING INTO ACCOUNT THE INVESTIGATION RESULTS, THE REPORTED EVENT WAS TRACED BACK TO THE UNEXPECTED AND PROGRESSIVE BUILD UP OF BIOLOGICAL MATERIAL (PLATELET AGGREGATES AND FIBRIN MASS) INSIDE THE OXYGENATOR FIBERS THAT AROSE DURING THE CASE AT CUSTOMER'S FACILITY. NO MANUFACTURING QUALITY DEVIATION POSSIBLY LINKED WITH THE OCCURRED PHENOMENON WAS ESTABLISHED: THE OXYGENATOR FIBERS WERE CONFIRMED TO BE PATENT AND NOT OCCLUDED DURING THE LABORATORY TEST AT LIVANOVA. PRESSURE DROP EXCURSION ACROSS THE OXYGENATOR IS A KNOWN PHENOMENON REPORTED IN LITERATURE IN ALL MEMBRANE OXYGENATORS. THE MAIN CAUSE OF THE PRESSURE EXCURSION HAS BEEN IDENTIFIED IN THE PLATELET ACTIVATION AND ADHESION WITHIN THE OXYGENATOR THAT PROGRESSES TO INCREASE RESISTANCE TO BLOOD FLOW DURING CARDIOPULMONARY BYPASS. THE FACTORS INFLUENCING PRESSURE EXCURSIONS CAN BE ASSIGNED TO THREE MAIN AREAS: - SURGERY CLINICAL IMPACT - CPB CLINICAL IMPACT - PATHOLOGICAL PATIENT CONDITIONS RESEARCH ON THE PHENOMENON CONSISTENTLY CONCLUDES THAT THE PRESSURE EXCURSION IS COMPLEX AND MULTIFACTORIAL AND IN MOST OF THE CASES NONE OF THE FACTORS CONSIDERED SINGULARLY CAUSES THE PHENOMENON. AN ACCURATE ANALYSIS AND MONITORING OF THE FACTORS IDENTIFIED CAN LEAD TO THE REDUCTION OF THE PHENOMENON DURING CPB. NEVERTHELESS, AT CURRENT STATE OF KNOWLEDGE, THE COMPLEX NATURE OF THE PHENOMENON DOES NOT ALLOW ITS COMPLETE ELIMINATION. THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Description of Event or Problem · 0

    SORIN GROUP ITALIA RECEIVED A REPORT THAT, DURING A PROCEDURE, THE FLOW THROUGH THE INSPIRE OXYGENATOR SUDDENLY STOPPED. PERFUSION TRIED TO TROUBLESHOOT WHAT CAUSED THE STOPPAGE OF FLOW AND COULD NOT DETERMINE THE CAUSE. MEDICAL TEAM ELECTED TO CHANGE OUT THE CIRCUIT, WENT BACK ON BYPASS WITH THE SECOND CIRCUIT AND FINISHED THE CASE. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133914 INSPIRE 7F OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA 03735 2410110150

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown