BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRE HVR HARDSHELL VENOUS/CARDIOTOMY RESERVOIR

    MDR report key: 16155961 · Received January 13, 2023

    Report

    Report Number
    9680841-2023-00002
    Event Type
    Injury
    Date Received
    January 13, 2023
    Date of Event
    December 16, 2022
    Report Date
    March 23, 2023
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSPIRE HVR HARDSHELL VENOUS/CARDIOTOMY RESERVOIR 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). IF IND/PREANDA, GIVE PROTOCOL #: THE INVOLVED INSPIRE HVR HARDSHELL VENOUS/CARDIOTOMY RESERVOIR IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE STANDALONE RESERVOIR (CATALOG NUMBER 050704) 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 ITALIA MANUFACTURES THE INSPIRE HVR HARDSHELL VENOUS/CARDIOTOMY RESERVOIR. THE INCIDENT OCCURRED IN UNITED STATES. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THE COMPLAINED RESERVOIR WAS DISCARDED AND THUS NO PHYSICAL INVESTIGATION COULD BE DONE. VISUAL EVIDENCE SHOWING THE HOLD-UP VOLUME OF THE VENOUS CHAMBER WAS PROVIDED. ACCORDING TO STANDARD OPERATING PROCEDURE, PLASMA AND COATING TREATMENTS (TO REDUCE BLOOD ACTIVATION) ARE CONDUCTED ON 100% OF HVR VENOUS RETURN FILTER. NO DEVIATIONS OR NON-CONFORMITIES WERE IDENTIFIED DURING MANUFACTURING PROCESS OF INVOLVED UNIT. REVIEW OF COMPLAINTS DATABASE REVEALED NO FURTHER SIMILAR CASE NOTIFIED FOR BATCH CONCERNED OF INSPIRE HVR FROM THE MARKET. THE INCREASED BREAKTHROUGH TIME OF BLOOD (TIME ELAPSED BETWEEN ITS INGRESS INTO THE HVR AND ITS RELEASE AFTER PASSING THROUGH THE FILTER) WAS LIKELY DUE TO PROGRESSIVE CLOTTING OF FILTER NETS DOWNSTREAM OF VENOUS RETURN PORT BY BUILD-UP OF BIOLOGICAL AGGREGATES/MATERIAL IN THE BOTTOM FILTER REGION. IN THIS OPERATING CONDITION, THE CLOGGED LOW SECTION OF VENOUS FILTER (WITH NET DIMENSIONS NARROWER THAN THE UP SECTION BY DESIGN) LEADS THE BLOOD TO HOLD UP TO THE UPPER SECTION WHICH IS ABLE TO LET THE BLOOD FLOW OUT BY MEANS OF THE LARGER NET DIMENSIONS. THE BLOOD CLOTTING ISSUE IS A MULTI-FACTORIAL PHENOMENON CORRELATED WITH CLINICAL PROCEDURE THERAPIES (E.G. ANTICOAGULANT PRESCRIPTION, HEPARIN COMPOSITION AND PRIMING COMPOSITION) AND PATIENT SPECIFIC HEALTH CONDITIONS. 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 BYPASS, PATIENT BLOOD WAS NOT FILTERED THROUGH THE INSPIRE HARD VENOUS RESERVOIR. MEDICAL TEAM CONNECTED THE VENOUS LINE TO A DIFFERENT RESERVOIR PORT AND THE ISSUE WAS SOLVED. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Description of Event or Problem · 0

    SEE INTIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1464275 INSPIRE HVR HARDSHELL VENOUS/CARDIOTOMY RESERVOIR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA SRL 03717 2206060179

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown