BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ DUAL CHANNEL

    MDR report key: 1962919 · Received November 11, 2010

    Report

    Report Number
    2921482-2010-00876
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 14, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K041550
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PASSED TESTING FOR DELIVERY ACCURACY. DURING TESTING, THE DEVICE DELIVERED A MEASURED VOLUME ON CHANNEL A OF 20.98 ML AND ON CHANNEL B 20.57 ML FROM AN EXPECTED DELIVERY OF 20 ML. DELIVERY ACCURACY FOR THIS DEVICE REQUIRES DELIVERY OF 20 ML +/- 1 ML (+/- 5%). BASED ON THE DATA VERIFIED, HOSPIRA COULD NOT ATTRIBUTE THE ISSUE TO THE DEVICE. THE PUMP HISTORY WAS DOWNLOADED AT THE MANUFACTURING FACILITY. THE CUSTOMER DID NOT PROVIDE AN EVENT DATE OR SPECIFIC PROGRAMMING PARAMETERS; THEREFORE, THE HISTORY CANNOT BE UTILIZED TO EVALUATE THE REPORTED EVENT. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE PT RECEIVED MORE MEDICATION THAN INTENDED. THE PUMP AND A 250ML CONTAINER WERE RETURNED TO THE BIOMEDICAL DEPARTMENT WITH A REPORT OF THE PUMP WAS "RUNNING TOO FAST." THE MEDICATION IN THE CONTAINER WAS NOT SPECIFIED. THE REPORT INDICATED THAT THE VTBI (VOLUME TO BE INFUSED) WAS LESS THAN 250ML "BUT THE BAG WENT DRY." NO TRACKING INFO WAS PROVIDED; THEREFORE, SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTED ADVERSE PT EVENTS WHILE THE PUMP WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, THE DEVICE PASSED TESTING. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMBIQ DUAL CHANNEL 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK