BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBE 2991

    MDR report key: 4103034 · Received September 19, 2014

    Report

    Report Number
    1722028-2014-00383
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    July 22, 2014
    Report Date
    August 25, 2014
    Manufacturer
    TERUMO BCT
    Product Code
    CAC
    PMA / PMN Number
    K893962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS RECORD WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF MDRS TO IDENTIFY RECORDS IN WHICH AN EVENT OCCURRED, BUT THE TYPE OF REPORTABLE EVENT WAS NOT INDICATED.

    Additional Manufacturer Narrative · 1

    THE MACHINE WAS CHECKED OUT AT THE CUSTOMER SITE. IT WAS DETERMINED THAT THERE WAS A MEMBRANE LEAK THAT CAUSED THE INCIDENT. THE SERVICE TECHNICIAN REPLACED THE MEMBRANED AND PERFORMED A PURGE OF THE HYDRAULIC FLUID. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    A ONE YEAR REVIEW OF THE DEVICE SERVICE HISTORY WAS PERFORMED AND NO ISSUES WERE IDENTIFIED RELATED TO THE REPORTED CONDITION. NO ADDITIONAL REPORTS HAVE BEEN RECEIVED FOR THIS DEVICE REGARDING THE REPORTED CONDITION. ROOT CAUSE: LEAKING MEMBRANE A DEFINITIVE ROOT CAUSE FOR THE MEMBRANE LEAK FAILURE REMAINS UNDETERMINED AT THIS TIME. POSSIBLE CAUSES FOR THE MEMBRANE LEAK INCLUDE A WORN OR DEFECTIVE MEMBRANE AND INADVERTENT PUNCTURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED WHILE THEY WERE DEFROSTING A SEMI-AUTOLOGOUS TRANSPLANT PRODUCT, THE COBE 2991 BEGAN TO LEAK THE COOLING LIQUID. THE GLYCOL SPREAD INTO THE KIT CONTAINING THE CELLS. SINCE THE CUSTOMER COULD NOT BE SURE THE GLYCOL DID NOT GET INTO THE ACTUAL PRODUCT BAG, THEY DECIDED TO DISCARD THE PRODUCT. THE CUSTOMER DEFROSTED A SECOND SEMI-TRANSPLANT ON ANOTHER MACHINE WITHOUT ANY INCIDENTS. DUE TO EU PERSONAL DATA PROTECTION LAWS, THE PATIENT INFORMATION IS NOT AVAILABLE FROM THE CUSTOMER. THE DISPOSABLE KIT IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. THIS REPORT IS BEING FILED IN RESPONSE TO THE CUSTOMER FILING A SAE REPORT WITH THEIR LOCAL AUTHORITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582570 COBE 2991 COBE 2991 BLOOD CELL PROCESSING SYSTEM CAC TERUMO BCT 000000000000091002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other