BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CSC14 BLOOD CARDIOPLEGIA SYSTEM

    MDR report key: 11066410 · Received December 23, 2020

    Report

    Report Number
    9680841-2020-00019
    Event Type
    Malfunction
    Date Received
    December 23, 2020
    Date of Event
    December 1, 2020
    Report Date
    February 15, 2021
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    LIVANOVA RECEIVED A REPORT ABOUT DETECTION OF BLOOD IN THE WATER COMPARTMENT OF CARDIOPLEGIA HEAT EXCHANGER CSC14 DURING PROCEDURE. THERE IS NOT REPORT OF ANY PATIENT INJURY. CLAIMED EXCHANGER WAS NOT REQUESTED. THE CLAIMED BLOOD TO WATER LEAKAGE HAS BEEN CONFIRMED BASED ON VISUAL EXAMINATION OF PICTURE PROVIDED BY THE CUSTOMER. CONSIDERING THAT DEVICES ARE 100% LEAK TESTED DURING MANUFACTURING, LIVANOVA BELIEVE THE MOST PROBABLE ROOT CAUSES ARE: (I) MINIMAL MATERIAL DAMAGE IN THE METAL SHEET OF THE HEAT EXCHANGER ASCRIBABLE TO DEFECTIVE SUPPLIED RAW MATERIAL OR (II) ISOLATED OPERATOR ERROR IN THE DISPOSITIONING OF THE NOT CONFORMING (LEAKING) UNIT. TO AVOID REOCCURRENCE, NEW VISION SYSTEM FOR THE INSPECTION OF THE METAL SHEET TO DETECT POSSIBLE RAW MATERIAL DAMAGES HAS BEEN IMPLEMENTED AT THE SUPPLIED SITE. IN ADDITION, IMPROVED LEAK TEST CONDITION MONITORING AND TRACKING HAVE BEEN IMPLEMENTED AT LIVANOVA SITE IN ORDER TO IMPROVE THE DEVICE MANAGEMENT DURING TESTING OF THE UNIT. THE COMPLAINED UNIT HAS BEEN MANUFACTURED BEFORE THE IMPLEMENTATION TO THE ABOVE DESCRIBED CORRECTIVE ACTIONS. THE RISK HAS BEEN ASSESSED AS ACCEPTABLE. LIVANOVA WILL MAINTAIN MONITORING THE MARKET.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED. THE CSC14 BLOOD CARDIOPLEGIA HEAT-EXCHANGER IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK (CATALOGUE NUMBER C20174 IT MIRANDOLA LOT 1906070164) THAT IS NOT DISTRIBUTED IN THE USA. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT INTO WHICH THE CARDIOPLEGIA HEAT-EXCHANGER WAS ASSEMBLED. AS THE STERILE CONVENIENCE PACK IS NOT DISTRIBUTED IN USA, THE UDI NUMBER IS NOT APPLICABLE. THE COMPLAINED CSC14 BLOOD CARDIOPLEGIA HEAT-EXCHANGER IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE STANDALONE CSC14 BLOOD CARDIOPLEGIA HEAT-EXCHANGER (CATALOG NUMBER P3740) IS REGISTERED IN THE USA (510(K) NUMBER: K012898). THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE CARDIOPLEGIA HEAT-EXCHANGER WAS ASSEMBLED. THE CARDIOPLEGIA HEAT-EXCHANGER WAS AVAILABLE FOR INVESTIGATION BUT CLEAR PICTURES VISIBLY CONFIRMING THE REPORTED ISSUE WERE PROVIDED AT THE SUBMISSION OF THE CASE. THEREFORE, THE DEVICE WAS NOT REQUESTED. SORIN GROUP ITALIA MANUFACTURES THE CSC14 BLOOD CARDIOPLEGIA HEAT-EXCHANGER. THE INCIDENT OCCURRED IN (B)(6). IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    SORIN GROUP(B)(4) HAS RECEIVED A REPORT THAT, DURING A PROCEDURE, THE PERFUSIONIST SAW BLOOD IN THE WATER COMPARTMENT OF THE CARDIOPLEGIA HEAT EXCHANGER CSC14. THERE IS NOT REPORT OF ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1533943 CSC14 BLOOD CARDIOPLEGIA SYSTEM HEAT-EXCHANGER, CARDIOPULMONARY BYPASS DTR SORIN GROUP ITALIA SRL 1903280059

    Patients

    Seq Age Sex Outcome Treatment
    1