BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DUAL CHANNEL

    MDR report key: 3805306 · Received March 6, 2014

    Report

    Report Number
    9615050-2014-01728
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    February 4, 2014
    Report Date
    February 4, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION AT THE SERVICE CENTER FOUND THAT THE DEVICE PASSES PERFORMANCE VERIFICATION TESTING WITHIN SPECIFICATION. HOWEVER, DURING REVIEW OF THE DEVICE HISTORY S321 MALFUNCTION ALARM CODES (PMC A MALFUNCTION CODE: PUMP QEP COUNT HIGH) WERE NOTED. THIS MALFUNCTION CODE INDICATES ENCODER COUNT FOR ONE FULL PLUNGER STROKE TOO HIGH, INDICATING A BROKEN ENCODER ON THE PLUNGER MOTOR. THE CUSTOMERS REPORTED S321 WAS NOT DUPLICATED IN TESTING; HOWEVER, WAS CONFIRMED IN THE DEVICE HISTORY. THIS REPORTER REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE DEVICE ALARMED WITH A S321 (MOTOR ERROR-PMC, LEFT) MALFUNCTION ALARM CODE. CUSTOMER CONTACT CONFIRMED THAT THE EVENT OCCURRED DURING START UP. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS, NO NEED FOR MEDICAL INTERVENTION, AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136137 SYMBIQ DUAL CHANNEL 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA