BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SINGLE CHANNEL

    MDR report key: 3983097 · Received July 2, 2014

    Report

    Report Number
    9615050-2014-04285
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THAT THE DEVICE ALARMED WITH A S321 (MOTOR ERROR - PMC, LEFT) MALFUNCTION ALARM CODE. DURING A REVIEW OF THE DEVICE HISTORY, S321 MALFUNCTION ALARMS WERE NOTED. FURTHER TESTING FOUND NO MOVEMENT FROM THE MOTOR SHAFT. THE PROBABLE CAUSE OF THE S321 MALFUNCTION ALARM CODE WITH THE MALFUNCTION SUBCODE "PUMP MOTOR LACK OF MOVEMENT" MAY BE DUE TO A BROKEN ENCODER OR HIGH DRIVE TRAIN FRICTION IN THE MR2 MOTOR. THIS REPORT REPRESENT ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT DURING PREVENTATIVE MAINTENANCE TESTING AT THE USER FACILITY, THE DEVICE ALARMED WITH A S321 (MOTOR ERROR - PMC, LEFT) SERVICE ALARM CODE. DURING THE VOLUME ACCURACY TEST AT THE USER FACILITY THE DEVICE ALARMED WITH A S321 - PUMP PLUNGER LACK OF MOVEMENT MALFUNCTION ALARM CODE. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS 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
    387980 SYMBIQ SINGLE CHANNEL 80FRN FRN HOSPIRA COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1