BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CAR

    MDR report key: 8598526 · Received May 10, 2019

    Report

    Report Number
    9680841-2019-00019
    Event Type
    Malfunction
    Date Received
    May 10, 2019
    Date of Event
    April 8, 2019
    Report Date
    July 25, 2019
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    SORIN GROUP ITALIA MANUFACTURES THE INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CARDIOTOMY RESERVOIR. THE INCIDENT OCCURRED IN (B)(6), JAPAN. INSPECTION OF THE PICTURE PROVIDED BY THE CUSTOMER CONFIRMED THE PRESENCE OF A WHITE EXTRANEOUS MATERIAL IN THE INTEGRATED ARTERIAL FILTER OF THE OXYGENATOR. THE COMPLAINED DEVICE WAS NOT MADE AVAILABLE FOR INVESTIGATION. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THE PRESENCE OF THE EXTRANEOUS MATERIAL IS ASCRIBABLE TO A HUMAN ERROR DURING THE MANUFACTURING AND DURING THE SUBSEQUENT VISUAL INSPECTION STEPS THAT SHOULD HAVE IDENTIFIED THE EXTRANEOUS MATERIAL AND DISCARDED THE UNIT. TO PREVENT REOCCURRENCE, THE MANUFACTURING OPERATORS WILL BE RETRAINED. THE FREQUENCY OF THIS TYPE OF EVENT IS LOW. LIVANOVA WILL KEEP MONITORING THE MARKET FOR SIMILAR EVENTS. H3 OTHER TEXT : DEVICE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT. THE COMPLAINED INSPIRE 6F M OXYGENATOR (CATALOG NUMBER 050702J, LOT 1803120219) IS NOT DISTRIBUTED IN THE USA, THEREFORE THE UDI IS NOT APPLICABLE. THE OXYGENATOR ITEM 050702J IS SIMILAR TO THE INSPIRE 6F OXYGENATOR 050702, WHICH IS DISTRIBUTED IN THE USA, FOR WHICH THE DEVICE IDENTIFIER IS 08033178112277. 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 050702J IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO THE INSPIRE 6F M OXYGENATOR 050702, 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 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CARDIOTOMY RESERVOIR. THE INCIDENT OCCURRED IN (B)(6). PER EXEMPTION NUMBER E2016005. THE INVOLVED OXYGENATOR WAS NOT MADE AVAILABLE 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.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Description of Event or Problem · 0

    SORIN GROUP (B)(4) HAS RECEIVED A REPORT THAT A EXTRANEOUS MATERIAL WAS IDENTIFIED INSIDE THE INTEGRATED ARTERIAL FILTER OF INSPIRE 6F M DURING PACKAGING INSPECTION PERFOMED BY THE ASSEMBLER (B)(4). THE EVENT OCCURRED PRIOR TO ANY PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392986 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CAR INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL DTZ SORIN GROUP ITALIA SRL 1803120219

    Patients

    Seq Age Sex Outcome Treatment
    1