BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRE HVR DUAL

    MDR report key: 20661779 · Received November 12, 2024

    Report

    Report Number
    9680841-2024-00031
    Event Type
    Injury
    Date Received
    November 12, 2024
    Date of Event
    October 15, 2024
    Report Date
    October 14, 2025
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NO PATIENT INFORMATION HAS BEEN PROVIDED. D.4. THE RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS 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 RESERVOIR IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE STANDALONE RESERVOIR (CATALOG NUMBER 050705) IS ALSO REGISTERED IN THE USA (510(K) NUMBER: K122844). THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE RESERVOIR WAS ASSEMBLED. H.11. LIVANOVA MANUFACTURES THE RESERVOIR. ACCORDING TO THE PERFUSIONIST, THE CIRCUIT THAT WAS PRIMED IN CASE OF AN EMERGENCY; PERFUSIONIST RE-CIRCULATED THE PRIME AND CONDUCTED ALL HIS SAFETY CHECKS. EVERYTHING WAS NORMAL. PERFUSIONIST HANDED UP THE AV LOOP TO THE TABLE AND THEN WAITED FOR ABOUT 1 HOUR FOR VEIN TO BE TAKEN. HE RE-CIRCULATED THROUGH THE MANIFOLD WAITING TO CANNULATE; HE INITIATED BYPASS AND HE NOTICED BUBBLING IN THE VENOUS SIDE OF THE DUAL RESERVOIR. HE TRIED TO FIND THE CAUSE OF THE BUBBLING BY SHUT OFF THE VACUUM ASSIST AND HE CONVERTED TO AN OPEN RESERVOIR WITH NO CHANGE. THEN, HE TURNED OFF THE SUCKERS AND VENTS WITH NO CHANGE. HE LOOKED AT THE VENOUS LINE WITH A LIGHT BUT COULD NOT SEE ANY AIR IN THE VENOUS LINE. PERFUSIONIST ASKED ANOTHER PERFUSION TO BRING IN THE BACKUP PUMP WITH A CIRCUIT SETUP ALREADY AND NOTIFIED THE SURGEON THAT HE WAS GOING TO CONVERT TO THE OTHER CIRCUIT. MEDICAL TEAM CAME OFF BYPASS, THEY COLLECTED ALL OF THE BLOOD FROM THE FIRST CIRCUIT INTO THE NEW CIRCUIT AND THEY WENT BACK ON BYPASS. THE NEW CIRCUIT HAD NO BUBBLING IN THE VENOUS SIDE OF THE DUAL RESERVOIR. THE PATIENT WAS WARM AND NOT AFFECTED BY THE CHANGE OF CIRCUITS. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    H11: NO VISUAL EVIDENCE OF THE REPORTED BUBBLING CONDITION WAS PROVIDED. INVOLVED UNIT WAS REQUESTED BACK FOR INVESTIGATION AT LIVANOVA FACILITY.: SMALL SECTIONS OF TUBES BELONGING TO THE PERFUSION TUBING SYSTEM WERE FOUND AT THE LEVEL OF RESERVOIR LID CONNECTORS AND RESERVOIR OUTLET CONNECTOR. SMALL DENT WAS FOUND AT VENOUS INLET CONNECTOR. RESERVOIR'S CARDIOTOMY SECTION WITH FILTERING MEDIA WAS FOUND BLOOD-STAINED, WHILE THE VENOUS RESERVOIR FILTERING MEDIA WAS CLEAN. NO EVIDENCE OF CLOTS WAS NOTED. A FUNCTIONAL FLOW TEST WAS PERFORMED, AFTER CLEANING THE DEVICE: VISUAL INSPECTION REVEALED NORMAL LIQUID CROSSING TIME IN THE WALLS OF THE VENOUS FILTER, AND NO PRESENCE OF BUBBLING WAS HIGHLIGHTED DURING LIQUID TRANSIT THROUGH VENOUS RESERVOIR OUTLET. THUS, THE ISSUE COULD NOT BE REPRODUCED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES ISSUE-RELATED DURING MANUFACTURING PROCESS OF INVOLVED UNIT. ANALYSIS OF COMPLAINTS DATABASE REVEALED NO OTHER SIMILAR CASES NOTIFIED FOR BATCH CONCERNED FROM THE MARKET, NOR ANY TRENDS WAS DETECTED FOR REPORTED CONDITION. BASED ON THE ABOVE ELEMENTS, NO QUALITY DEVIATION OR MALFUNCTION OF INVOLVED INSPIRE HVR RESERVOIR RELATED TO THE MANUFACTURING PROCESS WAS ESTABLISHED. THUS, A POTENTIAL ADVERSE EVENT PROCEDURE-RELATED WHICH RESULTED IN AN IMPROPER AIR HANDLING AND BUBBLING PHENOMENON COULD NOT BE EXCLUDED. THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP THE POST MARKET SURVEILLANCE.

    Description of Event or Problem · 0

    SORIN GROUP ITALIA RECEIVED A REPORT THAT RIGHT AFTER GOING ON BYPASS, MEDICAL TEAM NOTICED BUBBLING IN THE VENOUS RESERVOIR. THE PERFUSIONIST COULD NOT IDENTIFY WHY THE RESERVOIR WAS BUBBLING SO ANOTHER PERFUSIONIST BROUGHT IN THE BACKUP PUMP, MEDICAL TEAM ELECTED TO CAME OFF BYPASS AND SWITCH TO THE OTHER PUMP AND CIRCUIT. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1058436 INSPIRE HVR DUAL RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS DTN SORIN GROUP ITALIA 03708 2405220077

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown