BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED RESERVOIR

    MDR report key: 7142804 · Received December 22, 2017

    Report

    Report Number
    9680841-2017-00036
    Event Type
    Malfunction
    Date Received
    December 22, 2017
    Date of Event
    November 21, 2017
    Report Date
    April 27, 2018
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SORIN GROUP ITALIA MANUFACTURES THE INSPIRE 8F M HOLLOW FIBER OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6), CANADA. PER EXEMPTION NUMBER E2016005, SORIN GROUP ITALIA S.R.L. IS SUBMITTING THE REPORT FOR BOTH SORIN GROUP ITALIA S.R.L (MANUFACTURER) AND (B)(4). (IMPORTER). DURING FOLLOW-UP COMMUNICATION WITH THE CUSTOMER, SORIN GROUP ITALIA WAS PROVIDED THE PUMP SHEET FOR THE EVENT. ANALYSIS OF THE DATA CONFIRMED THAT THE CUSTOMER EXPERIENCED AN INCREASED TRANSMEMBRANE PRESSURE EVENT DURING THE PROCEDURE. BASED ON THE EVIDENCE FROM PREVIOUSLY INVESTIGATED CASES, SORIN GROUP ITALIA BELIEVES A LIKELY ROOT CAUSE OF THE INCREASED PRESSURE DROP TO BE PLATELET ADHESION AND FIBRIN LAYER DEPOSITION INSIDE THE OXYGENATOR. THE MOST PROBABLE ROOT CAUSE OF PLATELET ADHESION AND FIBRIN DEPOSITION IS MULTI-FACTORIAL AND INCLUDES THE CLINICAL PROCEDURE (E.G SURGICAL MATERIAL), THERAPIES (E.G. ANTICOAGULANT PRESCRIPTION, HEPARIN COMPOSITION AND PRIMING COMPOSITION) AND PATIENT SPECIFIC HEALTH CONDITIONS. THE FAILURE APPEARS TO NOT BE DEVICE-SPECIFIC.

    Additional Manufacturer Narrative · 0

    SORIN GROUP (B)(4) MANUFACTURES THE INSPIRE 8F M HOLLOW FIBER OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). PER EXEMPTION NUMBER E2016005, (B)(4). THE INVOLVED DEVICE WAS RETURNED TO SORIN GROUP (B)(4) FOR INVESTIGATION. THE DEVICE WAS SUBMITTED TO TESTING FOR VERIFICATION OF THE TRANSMEMBRANE PRESSURE DROP, WHICH FOUND THAT THE MEASURED PRESSURE DROP VALUES WERE WITHIN THE DEVICE SPECIFICATION. THE DEVICE WAS FOUND TO BE PERFORMING AS EXPECTED. AS THE ISSUE WAS NOT REPRODUCED, A ROOT CAUSE WAS NOT DETERMINED. HOWEVER, BASED ON THE EVIDENCE FROM PREVIOUSLY INVESTIGATED CASES, SORIN GROUP (B)(4) BELIEVES A LIKELY ROOT CAUSE OF THE INCREASED PRESSURE DROP TO BE PLATELET ADHESION AND FIBRIN LAYER DEPOSITION INSIDE THE OXYGENATOR. THE MOST PROBABLE ROOT CAUSE OF PLATELET ADHESION AND FIBRIN DEPOSITION IS MULTI-FACTORIAL AND INCLUDES THE CLINICAL PROCEDURE (E.G SURGICAL MATERIAL), THERAPIES (E.G. ANTICOAGULANT PRESCRIPTION, HEPARIN COMPOSITION AND PRIMING COMPOSITION) AND PATIENT SPECIFIC HEALTH CONDITIONS. THE FAILURE APPEARS TO NOT BE DEVICE-SPECIFIC.

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS NOT PROVIDED. THE INSPIRE 8F M HOLLOW FIBER OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK (LOT 1707250129) 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 8F 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 050703) IS 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 (B)(4) MANUFACTURES THE INSPIRE 8F M HOLLOW FIBER OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). PER EXEMPTION NUMBER E2016005. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. 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 RETURNED.

    Description of Event or Problem · 0

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE TRANS-MEMBRANE PRESSURE OF THE INSPIRE 8F M OXYGENATOR BEGAN TO INCREASE AFTER 20 MINUTES OF BYPASS AND CONTINUED TO RISE. THE PERFUSIONIST DECREASED THE FLOW RATE AND EVENTUALLY HAD TO STOP CIRCULATION DUE TO THE HIGH PRESSURE. FOLLOWING THE PROCEDURE, THE PERFUSIONIST WAS UNABLE TO DRAIN THE CIRCUIT BY ASPIRATING THE OXYGENATOR OUTLET. THE USER WAS ABLE TO DRAIN THE CIRCUIT AFTER ASPIRATING THE INLET. THE USER BELIEVES THAT DEBRIS OR CLOTS MAY HAVE CLOGGED THE OXYGENATOR AND CREATED HIGH INFLOW RESISTANCE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923105 INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED RESERVOIR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA S.R.L. 1708020205

    Patients

    Seq Age Sex Outcome Treatment
    1