BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SINGLE CHANNE

    MDR report key: 1860435 · Received September 27, 2010

    Report

    Report Number
    2921482-2010-00739
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    August 24, 2010
    Report Date
    September 1, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K041550
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED, THE PATIENT RECEIVED MORE MEDICATION THAN INTENDED. AT AN UNSPECIFIED TIME, THE DEVICE WAS PROGRAMMED TO DELIVER POTASSIUM CHLORIDE 40MEQ/100ML, AT A RATE OF 25ML/HR, FOR A DURATION OF 4HRS, AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AT 1500, APPROXIMATELY 2 HOURS AND 45 MINUTES AFTER THE DELIVERY WAS STARTED, THE NURSE WENT TO THE PATIENT'S ROOM IN RESPONSE TO AN ALARM CONDITION. AT THAT TIME, THE NURSE REPORTED, THE DEVICE WAS ALARMING FOR AIR IN LINE, THE CONTAINER WAS EMPTY AND THE DISPLAY INDICATED 31ML REMAINED TO BE DELIVERED. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR LOT # UNK| SYMBIQ TUBING SET,| LIST #16090