BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XTRA AUTOTRANSFUSION SYSTEM, PROCEDURE SET BX/125

    MDR report key: 7008919 · Received November 8, 2017

    Report

    Report Number
    9680841-2017-00030
    Event Type
    Malfunction
    Date Received
    November 8, 2017
    Date of Event
    October 6, 2017
    Report Date
    April 12, 2018
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    CAC
    UDI-DI
    08033178110020
    PMA / PMN Number
    K101586
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SORIN GROUP ITALIA MANUFACTURES THE XTRA AUTOTRANSFUSION SYSTEM, PROCEDURE SET BX/125. THE INCIDENT OCCURRED IN (B)(6). 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). THE COMPLAINED CIRCUIT (RBC BAG, BOWL AND TUBINGS) WAS RETURNED TO SORIN GROUP ITALIA FOR INVESTIGATION. VISUAL INSPECTION OF THE RETURNED RBC BAG CONFIRMED THE PRESENCE OF EXTRANEOUS BLACK PARTICLES. CHEMICAL ANALYSIS OF THE PARTICLES IDENTIFIED THE PRESENCE OF CARBON COMPATIBLE WITH THE GRAPHITE OF THE BOWL RING. INSPECTION OF THE GRAPHITE RING DID NOT IDENTIFY ANY SURFACE ABNORMALITIES OR DEFECTS. THE STATE OF THE RING WAS CONSISTENT WITH STANDARD USE. A POTENTIAL DEVIATION IN THE PHYSICAL/MECHANICAL CHARACTERISTICS OF THE DEVICE OR INCORRECT SEALING OF THE BOWL TOP COULD BE RULED OUT. IMPROPER SET UP OF THE DISPOSABLE IN THE MACHINE COULD ALSO NOT BE EXCLUDED. A DHR REVIEW OF THE COMPLAINED CIRCUIT CONFIRMED THAT THE DISPOSABLE WAS RELEASED CONFORMING TO PRODUCT SPECIFICATIONS. A REVIEW FOR SIMILAR EVENTS CONFIRMED THAT THIS IS AN ISOLATED CASE. AS NO SPECIFIC ROOT CAUSE COULD BE IDENTIFIED, CORRECTIVE ACTIONS WERE NOT DETERMINED.

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS NOT PROVIDED. THE AGE OF THE DEVICE WAS CALCULATED AS THE TIME ELAPSED BETWEEN THE DEVICE STERILIZATION AND THE DATE OF THE EVENT. (B)(4). SORIN GROUP (B)(4) MANUFACTURES THE XTRA AUTOTRANSFUSION SYSTEM, PROCEDURE SET BX/125. 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 RETURNED TO SORIN GROUP (B)(4) FOR INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT

    Description of Event or Problem · 0

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT SMALL (APPROXIMATELY 2-3 MM IN SIZE) BLACK PARTICLES WERE NOTED WITHIN THE SALVAGED BLOOD THAT WAS PROCESSED WITH THE XTRA AUTOTRANSFUSION SYSTEM AND SENT TO THE RE-INFUSION BAG. RE-INFUSION WAS NOT PERFORMED AND THE WHOLE PROCEDURE SET WAS PUT ASIDE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790768 XTRA AUTOTRANSFUSION SYSTEM, PROCEDURE SET BX/125 APPARATUS, AUTOTRANSFUSION CAC SORIN GROUP ITALIA BOWL SET X/125 1708020126 08033178110020

    Patients

    Seq Age Sex Outcome Treatment
    1