BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CSC14 BLOOD CARDIOPLEGIA SYSTEM

    MDR report key: 9207155 · Received October 18, 2019

    Report

    Report Number
    9680841-2019-00035
    Event Type
    Malfunction
    Date Received
    October 18, 2019
    Date of Event
    September 19, 2019
    Report Date
    October 18, 2019
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 (LOT 1905270109) THAT IS NOT DISTRIBUTED IN THE USA. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT INTO WHICH THE OXYGENATOR 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 OXYGENATOR WAS ASSEMBLED. SORIN GROUP (B)(4) MANUFACTURES THE CSC14 BLOOD CARDIOPLEGIA HEAT-EXCHANGER. THE INCIDENT OCCURRED IN (B)(6). A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THE COMPLAINED CSC14 WAS RECEIVED AT LIVANOVA FACILITIES AND SUBJECTED TO LEAK TEST. THE LEAK TEST REPRODUCED REPORTED LEAKAGE. THE RETURNED CSC14 WAS SECTIONED TO IDENTIFY THE SOURCE OF THE LEAKAGE: TWO FISSURES OF NAKED-EYE VISIBLE RANGE DIMENSIONS WERE IDENTIFIED IN THE SECTIONED METAL SHEET. NEITHER TRACE OF CORROSION NOR ANY METAL DEGRADATION COULD BE IDENTIFIED IN THE METAL SHEET BY THE FISSURES AREA. COMPLAINT REVIEW REVEALED THAT THIS IS THE SECOND EVENT REGISTERED FOR THIS ISSUE IN LAST THREE YEARS WITH NEARLY (B)(4) DISTRIBUTED UNITS WORLDWIDE. BASED ON SGI¿S RISK ANALYSIS PROCEDURE, THE PROBABILITY OF HARM IS INCREDIBLE (LESS THAN 0.001%), THE OVERALL RESIDUAL RISK OF THE EVENT IS CONSIDERED ACCEPTABLE. LIVANOVA INVESTIGATION SUGGESTS THE MOST PROBABLE ROOT CAUSE IS RELATED TO AN ISOLATED OPERATOR ERROR. TO PREVENT REOCCURRENCE, AN AWARENESS SESSION WITH ALL OPERATOR HAS BEEN HELD TO IMPROVE AWARENESS ON THIS TYPE OF ISSUES. IN ADDITION, LIVANOVA HAS ISSUED A CAPA PROJECT TO IMPLEMENT ACTION TO FURTHER REDUCE THE ALREADY LOW PROBABILITY OF AN OPERATOR ERROR DURING FINAL LEAK TEST.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) HAS RECEIVED A REPORT THAT, DURING A PROCEDURE, AFTER THE ADMINISTRATION OF THE CARDIOPLEGIC SOLUTION, 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
    1002160 CSC14 BLOOD CARDIOPLEGIA SYSTEM HEAT-EXCHANGER, CARDIOPULMONARY BYPASS DTR SORIN GROUP ITALIA SRL 1903280059

    Patients

    Seq Age Sex Outcome Treatment
    1