BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CSC14 BLOOD CARDIOPLEGIA SYSTEM

    MDR report key: 5240304 · Received November 20, 2015

    Report

    Report Number
    9680841-2015-00495
    Event Type
    Malfunction
    Date Received
    November 20, 2015
    Date of Event
    October 1, 2015
    Report Date
    October 5, 2015
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. AT THE DATE OF THE PRESENT REPORT, THE UNIT HAS NOT BEEN RETURNED TO THE MANUFACTURER FACILITIES FOR INVESTIGATION. THE CSC14 CARDIOPLEGIA DEVICE P3740J IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO THE CSC14 CARDIOPLEGIA DEVICE 025310, WHICH IS DISTRIBUTED IN THE USA (510K#: K012898). SORIN GROUP (B)(4) MANUFACTURES THE CSC14 BLOOD CARDIOPLEGIA DEVICE. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT A FOREIGN PARTICLE WAS FOUND INSIDE THE CSC14 CARDIOPLEGIA DEVICE DURING A SUPPLIER INSPECTION. AS THE IMPURITY WAS FOUND BY THE SUPPLIER, THERE WAS NO PATIENT INVOLVEMENT. THE INVESTIGATION IS ON GOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    DATE RETURNED TO MANUFACTURER: 01/07/2016. SORIN GROUP (B)(4) MANUFACTURES THE CSC14 BLOOD CARDIOPLEGIA DEVICE. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT A FOREIGN PARTICLE WAS FOUND INSIDE THE CSC14 CARDIOPLEGIA DEVICE DURING A SUPPLIER INSPECTION. AS THE IMPURITY WAS FOUND BY THE SUPPLIER, THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINED UNIT WAS RETURNED TO SORIN GROUP (B)(4) FOR FURTHER INVESTIGATION. VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THE REPORTED ISSUE. A PARTICLE WAS DISCOVERED ATTACHED TO THE BUBBLE TRAP NET OF THE DEVICE. NO OTHER ABNORMALITIES OR DEFECTS WERE IDENTIFIED THROUGHOUT THE VISUAL INSPECTION. THE ISSUE RESULTED FROM THE PRESENCE OF A SMALL IMPERFECTION IN THE FRAME AROUND THE NET OF THE BUBBLE-TRAP. IMPERFECTIONS IN THE NET AND THE FRAME THAT ARE PRESENT DURING ASSEMBLY ONTO TO THE POLYCARBONATE BY ULTRASONIC WELDING CAN CAUSE DEFORMITIES WHICH GENERATE THIS KIND OF PARTICLE. OPERATORS ARE TRAINED TO IDENTIFY IMPERFECTIONS AND DISCARD THE DEVICE IN THE PRESENCE OF SUCH A DEFECT. THE ROOT CAUSE FOR THIS ISSUE WAS IDENTIFIED TO BE FAILURE TO IDENTIFY AND DISCARD A DEFECTIVE COMPONENT DURING MANUFACTURING. THE MANUFACTURING DEPARTMENT HAS BEEN FORMALLY INFORMED TO PROVIDE AWARENESS TO OPERATORS ON HOW TO CORRECTLY IDENTIFY NON-ACCEPTABLE COMPONENTS AND DISCARD THEM. RETRAINING HAS BEEN CONDUCTED AND THE PERSONNEL RESPONSIBLE FOR THIS LOT HAVE BEEN DIRECTLY ADDRESSED TO BE MADE AWARE OF THE REPORTED ISSUE. A REVIEW OF THE DHR COULD NOT IDENTIFY AND DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE ISSUE. NO TREND HAS BEEN IDENTIFIED AND NO FURTHER ACTION IS REQUIRED. SORIN GROUP (B)(4) WILL CONTINUE TO MONITOR THE MARKET FOR TRENDS RELATED TO THIS TYPE OF ISSUE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT A FOREIGN PARTICLE WAS FOUND INSIDE THE CSC14 CARDIOPLEGIA DEVICE DURING A SUPPLIER INSPECTION. AS THE IMPURITY WAS FOUND BY THE SUPPLIER, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769157 CSC14 BLOOD CARDIOPLEGIA SYSTEM HEAT EXCHANGER, CARDIOPULMONARY BYPASS DTR SORIN GROUP ITALIA N/A 1409180120

    Patients

    Seq Age Sex Outcome Treatment
    1