BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL

    MDR report key: 8440408 · Received March 21, 2019

    Report

    Report Number
    9680841-2019-00013
    Event Type
    Malfunction
    Date Received
    March 21, 2019
    Date of Event
    February 19, 2019
    Report Date
    June 10, 2019
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    UDI-DI
    08033178112376
    PMA / PMN Number
    K130209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SORIN GROUP ITALIA MANUFACTURES THE INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL. THE INCIDENT OCCURRED IN ROME, ITALY. 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). VISUAL INSPECTION OF THE RETURNED OXYGENATOR MODULE CONFIRMED THE PRESENCE OF AN EXTRANEOUS BLACK MATERIAL BY THE INTEGRATED ARTERIAL FILTER. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATION NOR NON-CONFORMITY RELEVANT TO THE REPORTED ISSUE. LIVANOVA BELIEVES THE PRESENCE OF THE BLACK PIECE IS ASCRIBABLE TO A HUMAN ERROR DURING THE MANUFACTURING AND DURING THE SUBSEQUENT VISUAL INSPECTION STEPS THAT SHOULD HAVE IDENTIFIED THE EXTRANEOUS BLACK MATERIAL AND DISCARD THE UNIT. TO PREVENT REOCCURRENCE, THE MANUFACTURING FLOOR WILL BE RETRAINED. THE FREQUENCY OF THIS TYPE OF EVENT IS REMOTE (0.01% < P1 = 0.1%) . LIVANOVA WILL KEEP MONITORING THE MARKET FOR SIMILAR EVENTS.

    Additional Manufacturer Narrative · 0

    THE ISSUE OCCURRED PRIOR TO ANY PATIENT INVOLVEMENT. THE AGE OF THE DEVICE WAS CALCULATED AS THE TIME ELAPSED BETWEEN DEVICE STERILIZATION AND THE DATE OF THE EVENT. (B)(4). SORIN GROUP ITALIA MANUFACTURES THE INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL. 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 ITALIA FOR INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE NOT YET RETURNED.

    Description of Event or Problem · 0

    SORIN GROUP ITALIA HAS RECEIVED A REPORT THAT, DURING DEVICE SET-UP, A BLACK FOREIGN PARTICLE WAS IDENTIFIED BY THE OUTLET SIDE OF INSPIRE 6F INTEGRATED ARTERIAL FILTER. THE ISSUE WAS IDENTIFIED PRIOR TO ANY PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232507 INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CAR DTZ SORIN GROUP ITALIA SRL 6F PH.I.S.I.O. 1901150003 08033178112376

    Patients

    Seq Age Sex Outcome Treatment
    1