BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CSC14 BLOOD CARDIOPLEGIA SYSTEM

    MDR report key: 5494225 · Received March 10, 2016

    Report

    Report Number
    9680841-2016-00106
    Event Type
    Malfunction
    Date Received
    March 10, 2016
    Date of Event
    February 6, 2016
    Report Date
    February 13, 2016
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 INVESTIGATION. VISUAL INSPECTION OF THE RETURNED UNIT CONFIRMED THE PRESENCE OF A FOREIGN PARTICLE WITHIN THE FRAME AROUND THE NET OF THE BUBBLE TRAP. THE FOREIGN PARTICLE WAS NOT IDENTIFIED BY THE VISUAL CONTROLS PERFORMED BY MANUFACTURING OPERATORS DURING ASSEMBLY. THE MANUFACTURING FLOOR HAS BEEN MADE AWARE OF THIS ISSUE. TO PREVENT RECURRENCE, A TRAINING PROGRAM WAS IMPLEMENTED TO PERIODICALLY SENSITIZE AND RETRAIN PERSONNEL REGARDING COMPLAINTS THAT ARE ATTRIBUTABLE TO HUMAN ERRORS ON THE MANUFACTURING FLOOR. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED FAILURE. SORIN GROUP (B)(4) WILL CONTINUE TO MONITOR THE MARKET FOR TRENDS RELATED TO THIS TYPE OF ISSUE.

    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 (B)(4), WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K012898). THE FOREIGN PARTICLE WAS DISCOVERED DURING INCOMING INSPECTION PRIOR TO USE. 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 INVOLVED DEVICE HAS BEEN REQUESTED FOR RETURN: IT WILL BE SUBMITTED TO LABORATORY TESTS AND INVESTIGATION AS SOON AS RECEIVED, TO INVESTIGATE THE ROOT CAUSE OF THE COMPLAINED MALFUNCTION.

    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
    149622 CSC14 BLOOD CARDIOPLEGIA SYSTEM HEAT EXCHANGER, CARDIOPULMONARY BYPASS DTR SORIN GROUP ITALIA 1507230022

    Patients

    Seq Age Sex Outcome Treatment
    1