BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS LVP (8100)

    MDR report key: 4093075 · Received September 10, 2014

    Report

    Report Number
    MW5038178
    Event Type
    Injury
    Date Received
    September 10, 2014
    Date of Event
    August 6, 2014
    Report Date
    September 10, 2014
    Manufacturer
    CARFUSION
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CLAMP ON IV TUBING MALFUNCTIONED WITH ALARIS CHANNEL CAUSING PT TO RECEIVE A BOLUS OF NITRO, WHICH DROPPED PT'S B/P TEMPORARILY. PHENYLEPHRINE STARTED AND PLACED PT IN TRENDELENBURG TO TREAT PT'S HYPOTENSION. NITRO WAS THEN DISCONTINUED. NO PT HARM. THE SAFETY CLAMP ON ALARIS 8100 LVP DOOR LATCH HAD BROKEN WITHOUT THE NURSE'S KNOWLEDGE. THE LV THEN ALARMED, THE NURSE COULDN'T GET THE ALARM TO STOP. SHE OPENED THE DOOR AND REMOVED THE IV SET. THE CLAMP ON THE IV SET REMAINED OPEN BECAUSE OF THE BROKEN LATCH. THE NURSE SET ASIDE THE IV SET WITHOUT REALIZING IT WAS FREE-FLOWING. AFTER A SHORT TIME, SHE REALIZED WHAT WAS HAPPENING AND CLAMPED OFF THE SET STOPPING THE FLOW OF MEDICATION INTO THE PT. ALARIS MODULE WAS REMOVED FROM SERVICE AND SENT TO CLINICAL ENGINEERING FOR INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559630 ALARIS LVP (8100) ALARIS LVP (8100) FRN CARFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Life Threatening| R