BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY

    MDR report key: 8342856 · Received February 15, 2019

    Report

    Report Number
    9680841-2019-00005
    Event Type
    Malfunction
    Date Received
    February 15, 2019
    Date of Event
    January 15, 2019
    Report Date
    April 26, 2019
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SORIN GROUP ITALIA MANUFACTURES THE INSPIRE 6 START HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR. THE INCIDENT OCCURRED IN BENGALURU, INDIA. 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 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 BOTTOM OF THE OXYGENATOR. THE REVIEW OF THE DEVICE HISTORY RECORD OF THE CLAIMED OXYGENATOR LOT CONFIRMED THAT THE DEVICE WAS RELEASED IN COMPLIANCE WITH MANUFACTURER SPECIFICATIONS. TO PERFORM THE TESTING, THE DEVICE WAS EXTENSIVELY RINSED BUT IT WAS NOT POSSIBLE TO REMOVE MOST OF THE BIOLOGICAL TRACES RESIDUES. THE INVOLVED UNIT WAS FOUND TO BE WORKING COMPLIANT TO TECHNICAL SPECIFICATIONS. DURING THE TEST, A LEAK WAS OBSERVED FROM THE BOTTOM OF THE UNIT ORIGINATED FROM SOME DAMAGED OXYGENATOR FIBERS BUNDLE CAPILLARIES. BASED ON THE EVIDENCE OF DEVICE INSPECTIONS 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. BASED ON MEDICAL LITERATURE, 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 BELIEVES THAT THE BREAKAGE OF THE FIBER BUNDLE CAPILLARIES OBSERVED DURING THE LABORATORY TESTING (AND NOT DESCRIBED BY THE CUSTOMER) WAS THE CONSEQUENCE OF THE DECONTAMINATION TREATMENT AND TRANSPORTATION/STORAGE CONDITIONS AFTER THE EVENT. LIVANOVA WILL KEEP MONITORING THE MARKET FOR SIMILAR EVENTS.

    Additional Manufacturer Narrative · 0

    THE COMPLAINED INSPIRE 6 START OXYGENATOR (CATALOG NUMBER 050709, LOT 1809100083) IS NOT DISTRIBUTED IN THE USA, THEREFORE THE UDI IS NOT APPLICABLE. THE OXYGENATOR ITEM 050709 IS SIMILAR TO THE INSPIRE 6 OXYGENATOR 050713, WHICH IS DISTRIBUTED IN THE USA, FOR WHICH THE DEVICE IDENTIFIER IS (B)(4). THE AGE OF THE DEVICE WAS CALCULATED AS THE TIME ELAPSED BETWEEN DEVICE STERILIZATION AND THE DATE OF THE EVENT. (B)(4). THE PRODUCT ITEM 050709 IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO THE INSPIRE 6 OXYGENATOR 050713, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K130209). THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED OXYGENATOR. SORIN GROUP (B)(4) MANUFACTURES THE INSPIRE 6 START HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR. THE INCIDENT OCCURRED IN (B)(4). PER EXEMPTION NUMBER E2016005. THE CONNECTOR THAT DETACHED FROM THE LINE WAS NOT ASSEMBLED BY SORIN GROUP (B)(4).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. DEVICE NOT YET RETURNED.

    Description of Event or Problem · 0

    SORIN GROUP (B)(4) HAS RECEIVED A REPORT THAT, DURING A PROCEDURE, HIGH PRE-MEMBRANE PRESSURE OF OXYGENATOR INSPIRE 6 START WAS OBSERVED. ACCORDING TO FOLLOW UP INFORMATION WITH THE CUSTOMER, AFTER 10 MINUTES THE PROCEDURE WAS STARTED, THE PUMP TUBING STARTED TO BULGING; AFTER 19 MINUTES THE CONNECTOR BETWEEN THE PUMP OUTLET TUBING AND THE OXYGENATOR INLET TUBING DETACHED FROM THE LINE, THE PATIENT WAS WEANED-OFF AND OXYGENATOR WAS CHANGED-OUT. THE CHANGE-OUT LASTED 10 MINUTES. THE PROCEDURE WAS COMPLETED WITH NO OTHER ISSUE. THERE IS NOT REPORT OF ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136529 INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR DTZ SORIN GROUP ITALIA SRL 1809100083

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR