BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DUAL CHANNEL

    MDR report key: 4253324 · Received November 12, 2014

    Report

    Report Number
    9615050-2014-06028
    Event Type
    Malfunction
    Date Received
    November 12, 2014
    Date of Event
    January 1, 2014
    Report Date
    October 13, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING THE DEVICE ALARMED WITH A S421 (MOTOR ERROR-PMC, RIGHT) MALFUNCTION ALARM CODE. THE CASSETTE DOOR WOULD NOT CLOSE AND WAS STUCK IN THE OPEN POSITION. THE ALARM COULD NOT BE CLEARED. THE DEVICE WAS DISASSEMBLED AND A VISUAL INSPECTION FOUND THAT THE MR2 MOTOR ON CHANNEL B HAD A BROKEN RTV SEAL. AS A RESULT, THE MR2 MOTOR WAS LOOSE AND MOVED OUT OF POSITION. THE PROBABLE CAUSE FOR S421 MALFUNCTION AND THE CASSETTE DOOR NOT CLOSING WAS DUE TO A BROKEN RTV SEAL ON THE MR2 MOTOR. AN INVESTIGATION FOUND THAT THE RTV ISSUES WERE CAUSED EITHER BY RTV BEING UNDER APPLIED TO THE SPECIFICATION OR EXCESS GREASE FROM THE O-RING INSTALLATION WAS NOT REMOVED AND THE RTV IS APPLIED OVER THE GREASE. THE RTV MAY NOT HOLD THE MOTOR IN PLACE UNDER A LOAD WHICH WILL RESULT IN AN S321/S421 MALFUNCTION ALARM CODES. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE SERVICE CENTER FOR A REPORT FROM THE CUSTOMER CONTACT THAT THE DEVICE DOOR B WOULD NOT CLOSE. THIS DOES NOT INDICATE A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CENTER, THE DEVICE ALARMED WITH A S421 (MOTOR ERROR-PMC, RIGHT) MALFUNCTION ALARM CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729589 SYMBIQ DUAL CHANNEL 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA