BEUDAMED
    FDA Adverse Event Summary report: N

    INSPIRE 6 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES

    MDR report key: 6151669 · Received December 7, 2016

    Report

    Report Number
    9680841-2016-00518
    Date Received
    December 7, 2016
    Date of Event
    September 19, 2016
    Report Date
    February 22, 2017
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    DTZ
    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 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR. THE INCIDENT OCCURRED IN (B)(6). (B)(4). EXEMPTION NUMBER E2016005. THE COMPLAINED OXYGENATOR WAS RETURNED TO SORIN GROUP (B)(4) AND SUBJECTED TO SIMULATED USED TESTING. THE OXYGENATOR WAS TESTED BOTH ACCORDING TO RELEVANT ISO STANDARD AND IN A WAY THAT SIMULATED THE USE CONDITION. BOTH FUNCTIONAL TESTS SHOWED THAT THE OXYGENATOR PERFORMED AS EXPECTED. BASED ON THE INVESTIGATION RESULTS, THE EVENT DOES NOT APPEAR TO BE ASCRIBABLE TO A DEVICE MALFUNCTION. THE MOST PROBABLE ROOT CAUSE OF THE EVENT IS MULTI-FACTORIAL INCLUDING INTERACTION WITH CLINICAL PROCEDURE AND PATIENT. AS NO DEVICE MALFUNCTION COULD BE IDENTIFIED AND THE FREQUENCY OF THIS KIND OF EVENT IS VERY LOW (B)(4), NO CORRECTIVE ACTION IS NECESSARY. SORIN GROUP (B)(4) WILL CONTINUE TO MONITOR FOR TRENDS RELATED TO THIS TYPE OF ISSUE.

    Additional Manufacturer Narrative · 1

    THE COMPLAINED INSPIRE 6 OXYGENATOR (CATALOG NUMBER 03706, LOT NUMBER 1602290132) IS A NON-STERILE UNIT THAT WAS ASSEMBLED INTO A CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE ITEM, LOT NUMBER AND EXPIRATION DATE PROVIDED REFER TO THE CONVENIENCE PACK. AS THE CONVENIENCE PACK IS NOT DISTRIBUTED IN THE USA, THE UDI IS NOT APPLICABLE. THE INSPIRE 6 OXYGENATOR IS SIMILAR TO THE OXYGENATOR 050717, WHICH IS DISTRIBUTED IN THE USA, FOR WHICH THE DEVICE IDENTIFIER IS (B)(4). THE COMPLAINED INSPIRE 6 OXYGENATOR WAS ASSEMBLED INTO A CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO THE INSPIRE 6 OXYGENATOR 050717, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K121909). THE DATE OF MANUFACTURE PROVIDED REFERS TO THE MANUFACTURE DATE OF THE CONVENIENCE PACK INTO WHICH THE COMPLAINED OXYGENATOR WAS ASSEMBLED. SORIN GROUP (B)(4) MANUFACTURES THE INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR. THE INCIDENT OCCURRED IN (B)(6). (B)(4). 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. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION HAS BEEN COMPLETED. (B)(4)

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE PO2 LEVELS OF THE INSPIRE 6 OXYGENATOR WERE DETECTED TO BE VERY LOW WHILE AT 100% FIO2 NEAR THE END OF THE PROCEDURE. THE PHYSICIAN ELECTED TO USE AN ARTIFICIAL RESPIRATOR AND NOT CHANGE OUT THE OXYGENATOR. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802129 INSPIRE 6 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA S.R.L. 1603290046

    Patients

    Seq Age Sex Outcome Treatment
    1