BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOSPIRA INC

    MDR report key: 793123 · Received December 12, 2006

    Report

    Report Number
    MW1041324
    Event Type
    Injury
    Date Received
    December 12, 2006
    Date of Event
    November 30, 2006
    Report Date
    December 4, 2006
    Manufacturer
    *
    Product Code
    DRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT'S WIFE CAME TO DOOR AND REPORTED THAT PT WAS EXPERIENCING A BURNING AND TINGLING SENSATION AT LEFT RADIAL ARTERIAL LINE SITE. I WENT AND LOOKED AT SITE, CHECKED HAND WARMTH, AND CAPILLARY REFILL. THE ARTERIAL LINE PRESSURE WAVEFORM WAS DAMPENED ON MONITOR. PRESSURE BAG WAS NOTED TO BE EMPTY, THEN TUBING TO MANIFOLD NOTED TO HAVE AIR IN LINE, AND THEN AIR NOTED TO ARTERIAL LINE SITE. BLOOD WAS ASPIRATED TO SAFESET, THEN STOPCOCK TO PT WAS TURNED OFF. A NEW FLUSH BAG WAS HUNG (NS), AND THE TUBING WAS FLUSHED AND RECONNECTED TO PT. HE THEN HAD A CORRECT WAVEFORM ON THE MONITOR. THE CARDIAC ANCP WAS HERE AT BEDSIDE. BLOOD COULD BE ASPIRATED, BUT THE SAFESET COULD NOT BE FLUSHED THE FULL 10CC. ONLY 7CC COULD BE FLUSHED. WE STARTED TO CHANGE THE MANIFOLD, BUT PT CONTINUED TO COMPLAIN OF A BURNING SENSATION AT SITE. ORDER TO DISCONTINUE ARTERIAL LINE. HOSP CONTACT NOTIFIED OF EQUIPMENT MALFUNCTION. TEAM LEADER ALSO NOTIFIED. MANIFOLD SENT FOR RETURN TO MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOSPIRA INC MONITORING KIT WITH 03ML FLUSH DEVICE DRS * * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention