BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL

    MDR report key: 8398022 · Received March 7, 2019

    Report

    Report Number
    9680841-2019-00009
    Event Type
    Malfunction
    Date Received
    March 7, 2019
    Date of Event
    November 12, 2018
    Report Date
    March 1, 2019
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS NOT PROVIDED. THE INSPIRE 6F M HOLLOW FIBER OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK (LOT 1809040166) THAT IS NOT DISTRIBUTED IN THE USA. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT INTO WHICH THE OXYGENATOR WAS ASSEMBLED. AS THE STERILE CONVENIENCE PACK IS NOT DISTRIBUTED IN USA, THE UDI NUMBER IS NOT APPLICABLE. THE AGE OF THE DEVICE WAS CALCULATED AS THE TIME ELAPSED BETWEEN DEVICE STERILIZATION AND THE DATE OF EVENT. (B)(4). THE COMPLAINED INSPIRE 6F M HOLLOW FIBER OXYGENATOR IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE STAND ALONE OXYGENATOR (CATALOG NUMBER: 050702) IS REGISTERED IN THE USA (510(K) NUMBER: K130209). THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE OXYGENATOR WAS ASSEMBLED. SORIN GROUP (B)(4) MANUFACTURES THE INSPIRE 6F M HOLLOW FIBER OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). PER EXEMPTION NUMBER E2016005. THE INVOLVED DEVICE HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP (B)(4) FOR INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. THE PRESENT REPORT WAS INITIALLY SUBMITTED ON TUESDAY, JANUARY 08TH, 2019. THE ACK 3 WAS NOT RECEIVED AND THE REPORT WAS RESUBMITTED ON TUESDAY, MARCH 05TH, 2019. DEVICE NOT YET RETURNED.

    Additional Manufacturer Narrative · 0

    SORIN GROUP ITALIA MANUFACTURES THE INSPIRE 6F M HOLLOW FIBER OXYGENATOR. THE INCIDENT OCCURRED IN GENT, BELGIUM. PER EXEMPTION NUMBER E2016005, SORIN GROUP ITALIA S.R.L. IS SUBMITTING THE REPORT FOR BOTH SORIN GROUP ITALIA S.R.L (MANUFACTURER) AND LIVANOVA USA., INC. (IMPORTER). THE REVIEW OF THE DEVICE HISTORY RECORD OF THE CLAIMED OXYGENATOR LOT CONFIRMED THAT THE DEVICE WAS RELEASED IN COMPLIANCE WITH MANUFACTURER SPECIFICATIONS. THE INVOLVED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND SUBMITTED TO GAMMA RAY DECONTAMINATION PRIOR THE INSPECTION. THE VISUAL INSPECTION FOUND NO DEFECTS NOR NON-CONFORMITIES. BIOLOGICAL TRACES MAINLY COMPOSED BY RED DEPOSITS, LIKELY DUE TO FIBRIN DEPOSITION AND RED BLOOD CELLS, WERE VISIBLE IN THE ARTERIAL FILTER. TO SUBMIT THE DEVICE TO TEST FOR TRANSMEMBRANE PRESSURE VERIFICATION, THE DEVICE WAS EXTENSIVELY RINSED. HOWEVER, IT WAS NOT POSSIBLE TO REMOVE MOST OF BIOLOGICAL TRACES. THE TEST REPRODUCED THE CLAIMED ISSUE, THE PRESSURE DROP VALUES MEASURED DURING OUR LABORATORY TEST WERE ABOVE DEVICE SPECIFICATIONS. BASED ON THE EVIDENCE OF DEVICE INSPECTION AND ON PREVIOUS INVESTIGATED SIMILAR CASES, IT CAN BE CONFIRMED THAT THE INCREASE OF PRESSURE DROP HAS BEEN ASSOCIATED WITH PLATELET ADHESION AND FIBRIN LAYER DEPOSITION INSIDE THE OXYGENATOR. THE MOST PROBABLE ROOT CAUSE OF PLATELET ADHESION AND FIBRIN DEPOSITION IS MULTI-FACTORIAL AND INCLUDE CLINICAL PROCEDURE (E.G SURGICAL MATERIAL), THERAPIES (E.G. ANTICOAGULANT PRESCRIPTION, HEPARIN COMPOSITION AND PRIMING COMPOSITION) AND PATIENT SPECIFIC HEALTH CONDITIONS. ACCORDING TO SIMILAR CASES PREVIOUSLY INVESTIGATED THE ORIGIN OF THE ACTIVATION AND INTERACTION APPEAR TO BE MULTI-FACTORIAL IN NATURE AND NOT DEVICE SPECIFIC. FOR THIS REASON, NO SPECIFIC CORRECTIVE ACTION HAS BEEN IDENTIFIED AT THE PRESENT DATE. LIVANOVA WILL KEEP MONITORING THE MARKET FOR SIMILAR EVENTS. THE PRESENT REPORT WAS INITIALLY SUBMITTED ON TUESDAY, WEDNESDAY, 27 FEBRUARY, 2019 THE ACK 3 WAS NOT RECEIVED AND THE REPORT WAS RESUBMITTED ON TUESDAY, MARCH 08TH, 2019.

    Description of Event or Problem · 0

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT, DURING A CARDIOPULMONARY BYPASS, HIGH PREMEMBRANE PRESSURE WAS OBSERVED. THERE WAS NO REPORT OF PATIENT INJURY. DURING FOLLOW UP INFORMATION WITH THE CUSTOMER, ON DECEMBER 14TH, 2018, SORIN GROUP (B)(4) HAS BEEN INFORMED THAT NIPRIDE WAS ADMINISTERED TO THE PATIENT DURING THE CARDIOPULMONARY BYPASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192002 INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER DTZ SORIN GROUP ITALIA SRL 1808310005

    Patients

    Seq Age Sex Outcome Treatment
    1