BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XTRA COLLECTION SET

    MDR report key: 7641032 · Received June 27, 2018

    Report

    Report Number
    9680841-2018-00015
    Event Type
    Malfunction
    Date Received
    June 27, 2018
    Date of Event
    May 22, 2018
    Report Date
    August 27, 2018
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    CAC
    PMA / PMN Number
    K101586
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER WAS NOT PROVIDED. AS THE LOT NUMBER IS UNKNOWN, THE EXPIRATION DATE AND UNIQUE IDENTIFIER (UDI) NUMBER COULD NOT BE DETERMINED. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. AS THE LOT NUMBER IS UNKNOWN, THE AGE OF THE DEVICE COULD NOT BE DETERMINED. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. (B)(4). AS THE LOT NUMBER IS UNKNOWN, THE DEVICE MANUFACTURE DATE COULD NOT BE DETERMINED. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. SORIN GROUP (B)(4) MANUFACTURES THE XTRA COLLECTION SET TX. THE INCIDENT OCCURRED IN (B)(6). PER EXEMPTION NUMBER E2016005. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    SORIN GROUP ITALIA MANUFACTURES THE XTRA COLLECTION SET TX. THE INCIDENT OCCURRED IN BORDEAUX, FRANCE. 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 INVOLVED COLLECTION RESERVOIR WAS DISPOSED OF BY THE CUSTOMER AND NO PRODUCT TRACEABILITY WAS PROVIDED TO SORIN GROUP ITALIA. THEREFORE, UNIT INVESTIGATION AND A REVIEW OF MANUFACTURING RECORDS COULD NOT BE PERFORMED. NO DEVICE MALFUNCTION COULD BE CONFIRMED. THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, SORIN GROUP ITALIA BELIEVES THAT THE MOST PROBABLE ROOT CAUSE OF THE REPORTED ISSUE IS MULTI-FACTORIAL AND INCLUDES USE CONDITIONS, CLINICAL PROCEDURE THERAPIES (E.G. ANTICOAGULANT PRESCRIPTION, HEPARIN COMPOSITION AND PRIMING COMPOSITION) AND PATIENT SPECIFIC HEALTH CONDITIONS. IN AGREEMENT WITH THE CUSTOMER, A TRAINING MEETING HAS BEEN PLANNED AT CUSTOMER SITE. SORIN GROUP ITALIA WILL KEEP MONITORING THE MARKET FOR SIMILAR EVENTS. DEVICE DISPOSED OF BY CUSTOMER.

    Description of Event or Problem · 0

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE TIME REQUIRED TO FILTRATE BLOOD DURING A PROCEDURE WHEN UTILIZING AN XTRA COLLECTION SET TX WAS TOO LONG. THE CUSTOMER ALLEGED THAT THE FILTRATION MEMBRANE OF THE XTRA SYSTEM TANK DID NOT ADAPT TO THE VOLUME OF BLOOD BEING PROCESSED. THE MEDICAL TEAM ELECTED TO ADMINISTER A PLASMA-EXPANDER TO THE PATIENT. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484197 XTRA COLLECTION SET XTRA AUTOTRANSFUSION SYSTEM CAC SORIN GROUP ITALIA S.R.L. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR