BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS SYSTEM PUMP MODULE

    MDR report key: 1362047 · Received January 15, 2009

    Report

    Report Number
    2016493-2009-00008
    Event Type
    Other
    Date Received
    January 15, 2009
    Report Date
    January 9, 2009
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DATE OF EVENT UNK. A NURSE HAD A CONTINUOUS INFUSION RUNNING AT 100ML/HR, VTBI 1000ML AND AFTER 10 HOURS THERE WAS STILL ABOUT 200ML LEFT IN THE BAG. NO PT INJURY. NO FURTHER DETAILS KNOWN. IV PUMP AND SET WERE NOT SAVED. DISCUSSED POSSIBLE CAUSE OF UNDERINFUSION WITH THE ACCOUNT INCLUDING IMPROPER SET LOADING, ISSUE WITH IMPROPER HEAD HEIGHT AND BACK PRESSURE. TIP SHEET ON PROPER SET LOADING WAS PROVIDED TO HELP RE-EDUCATE THE STAFF. SALES REP MADE A SITE VISIT AND REITERATED PROPER SET LOADING AND IV SET UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SYSTEM PUMP MODULE FRN CARDINAL HEALTH ALARIS PRODUCTS 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other