BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRE HVR DUAL HARDSHELL VENOUS/CARDIOTOMY RESERVOIR

    MDR report key: 15823364 · Received November 18, 2022

    Report

    Report Number
    9680841-2022-00051
    Event Type
    Injury
    Date Received
    November 18, 2022
    Date of Event
    October 11, 2022
    Report Date
    January 19, 2023
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS NOT PROVIDED. THE INSPIRE HVR DUAL HARDSHELL VENOUS/CARDIOTOMY RESERVOIR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK (ITEM IN01169H, LOT 2206010125) THAT IS NOT DISTRIBUTED IN THE USA. THE LOT OF THE NON-STERILE RESERVOIR IS 2206080087 OR 2206060177. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT INTO WHICH THE RESERVOIR WAS ASSEMBLED. AS THE STERILE CONVENIENCE PACK IS NOT DISTRIBUTED IN USA, THE UDI NUMBER IS NOT APPLICABLE. THE COMPLAINED INSPIRE HVR DUAL HARDSHELL VENOUS/CARDIOTOMY RESERVOIR IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE STANDALONE RESERVOIR (CATALOG NUMBER 050705) IS 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 OXYGENATOR WAS ASSEMBLED. SORIN GROUP ITALIA MANUFACTURES THE INSPIRE HVR DUAL HARDSHELL VENOUS/CARDIOTOMY RESERVOIR. THE INCIDENT OCCURRED IN MANCHESTER, UNITED KINGDOM. THE INVOLVED RESERVOIR IS AVAILABLE AND HAS NOT BEEN REQUESTED FOR RETURN TO SORIN GROUP ITALIA FOR INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    LIVANOVA RECEIVED A REPORT OF INCREASED BREAKTHROUGH TIME RELEATED TO A VENOUS RETURN FILTER OF INSPIRE HARDSHELL VENOUS RESERVOIR (HVR). THERE WAS NO PATIENT IMPACT. REVIEW OF COMPLAINTS DATABASE REVEALED NO FURTHER SIMILAR CASE NOTIFIED FOR BATCH CONCERNED OF INSPIRE HVR FROM THE MARKET. CLEAR PICTURE SHOWING THE CLOGGED VENOUS FILTER SOCK WAS PROVIDED. THROUGH FOLLOW-UP COMMUNICATION WITH THE CUSTOMER, LIVANOVA LEARNED THAT NO ADDITIONAL MEDICAL INTERVENTION WAS EVENTUALLY CONDUCTED BY MEDICAL TEAM. PERFUSIONIST WAS READY TO TAKE ACTION IF RESTRICTED VENOUS BLOOD FLOW RATE OCCURRED AND IN THE END THERE WAS NO NEED TO MAKE CHANGES TO THE CIRCUIT. AS PER AVAILABLE INFORMATION, IT IS REASONABLE TO ASSUME THAT THE INCREASED BREAKTHROUGH TIME OF BLOOD ENTERING THE HVR WAS CAUSED BY PROGRESSIVE CLOTTING OF THE FILTER NETS 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. DHR ANALYSIS CONFIRMED THAT BOTH PLASMA AND COATING TREATMENTS ARE CONDUCTED ON 100% OF HVR VENOUS RETURN FILTER (COATING WITH PHOSPHORYLCHOLINE FOR HEMO-COMPATIBILITY OF THE SURFACES TO PREVENT ACTIVATION OF THE BLOOD IN CONTACT WITH THE SAME). A VISUAL CHECK IS PERFORMED AT THE END OF ABOVE STEPS TO VERIFY THE ABSENCE OF WET AREAS, DEPOSITS, OPACITY AND OTHER DEFECTS. FINALLY, THE EMPTY HVR WITH NO FILTER PRE-ASSEMBLED UNDERGOES COATING TREATMENT TOO. NO DEVIATIONS OR NON-CONFORMITIES WERE IDENTIFIED DURING MANUFACTURING PROCESS OF INVOLVED UNIT. BASED ON COLLECTED EVIDENCE, THE MOST LIKELY ROOT CAUSE OF COMPLAINED EVENT HAS BEEN ASSIGNED TO UNEXPECTED BLOOD ACTIVATION IN THE SYSTEM, RESULTING IN PARTIAL OCCLUSION OF FILTERING ELEMENTS AND CONCOMITANT REDUCTION OF OPEN SURFACE FOR BLOOD FLOW. 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. SINCE NO MEDICAL INTERVENTION WAS EVENTUALLY CONDUCTED BY MEDICAL TEAM, THE PRESENT EVENT HAS BEEN RE-ASSESSED AS NON-REPORTABLE EVENT. 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 HAS RECEIVED A REPORT THAT, DURING A SHORT BYPASS CASE, THE PATIENT BLOOD INTO THE FILTER OF THE INSPIRE HVR DUAL HARDSHELL VENOUS/CARDIOTOMY RESERVOIR SEEMED AS IF IT WAS BACKING UP, DESPITE THE CARDIOTOMY FILTER BEING FINE AND HAVING GOOD ACTS. MEDICAL TEAM ELECTED TO TAKE STEPS TO FACILITATE BYPASSING THIS FILTER AND PREPARED TO ATTACH THE VENOUS LINE TO A 3/8 PORT. 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
    228293 INSPIRE HVR DUAL HARDSHELL VENOUS/CARDIOTOMY RESERVOIR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA SRL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown