BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSPIRE 8F HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS CARDIOTOMY RES

    MDR report key: 6167136 · Received December 12, 2016

    Report

    Report Number
    9680841-2016-00519
    Event Type
    Death
    Date Received
    December 12, 2016
    Date of Event
    November 10, 2016
    Report Date
    May 19, 2017
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    DTZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SORIN GROUP (B)(4) MANUFACTURES THE INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS CARDIOTOMY RESERVOIR. THE INCIDENT OCCURRED IN (B)(6). (B)(4). EXEMPTION NUMBER E2016005. THE INVOLVED DEVICE WAS RETURNED TO SORIN GROUP (B)(4) FOR INVESTIGATION. THE OXYGENATOR DEVICE WAS FOUND TO BE CONFORMING TO SPECIFICATIONS. NO ANOMALIES RELATED TO THE COMPLAINED EVENT WERE IDENTIFIED, AND NO SIMILAR REPORTS OF DEPOSITS IN THE ARTERIAL FILTER HAVE BEEN REPORTED FOR THE COMPLAINED LOT. AN ATTEMPT TO IDENTIFY THE ORIGIN OF THE DEPOSIT WAS MADE THROUGH A HISTOLOGICAL EXAMINATION. HOWEVER, DUE TO POOR PRESERVATION OF THE BIOLOGICAL SUBSTANCES, A DEFINITIVE CONCLUSION COULD NOT BE REACHED. THROUGH FOLLOW-UP COMMUNICATION. SORIN GROUP (B)(4) LEARNED THAT A MANEUVER TO DIVERT THE DEPOSIT IN THE ARTERIAL FILTER WAS REPORTEDLY ATTEMPTED DURING THE CASE. THIS KIND OF MANEUVER HAS NO PROVEN EFFICACY AND COULD HAVE INCREASED THE LIKELIHOOD OF SOLID EMBOLI RELEASE TO THE PATIENT. FOR THIS TYPE OF SITUATION, THE INSTRUCTION FOR USE RECOMMENDS AN OXYGENATOR REPLACEMENT. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATION OR NON-CONFORMITY RELEVANT TO THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 1

    THE COMPLAINED INSPIRE 8F HOLLOW FIBER OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE CATALOG NUMBER, LOT NUMBER, AND EXPIRATION DATE REFER TO THE STERILE FINISHED PRODUCT INTO WHICH THE OXYGENATOR WAS ASSEMBLED. AS THE STERILE FINISHED PRODUCT IS NOT DISTRIBUTED IN USA, THERE IS NO UNIQUE IDENTIFIER (UDI) NUMBER. HOWEVER, THE COMPLAINED DEVICE IS SIMILAR TO INSPIRE 8F OXYGENATOR CATALOG NUMBER 050716, WHICH IS DISTRIBUTED IN THE USA, FOR WHICH THE DEVICE IDENTIFIER IS (B)(4). THE COMPLAINED INSPIRE 8F 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 050716) 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 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS CARDIOTOMY RESERVOIR. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THE DEVICE HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP (B)(4) FOR INVESTIGATION. HOWEVER, IT HAS NOT YET BEEN RETURNED. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT TWO AIR BUBBLE ALARM EVENTS OCCURRED AND STOPPED THE MAIN PUMP DURING A MITRAL VALVE REPAIR PROCEDURE. THE TWO ALARMS OCCURRED WITHIN TEN MINUTES OF EACH OTHER AND WERE PROMPTLY RESOLVED. AT THE END OF THE PROCEDURE, THE PERFUSIONIST IDENTIFIED WHITE MATTER (REPORTED TO BE FIBRIN) IN THE INTEGRATED ARTERIAL FILTER OF THE INSPIRE 8F HOLLOW FIBER OXYGENATOR. THE PATIENT DID NOT REGAIN CONSCIOUSNESS FOLLOWING THE PROCEDURE AND EXPIRED ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818248 INSPIRE 8F HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS CARDIOTOMY RES OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA S.R.L. 1605310056

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death