BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS

    MDR report key: 1843541 · Received September 20, 2010

    Report

    Report Number
    MW5017554
    Event Type
    Injury
    Date Received
    September 20, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 20, 2010
    Manufacturer
    CARE FUSION
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT STARTED 250 CCS BAG OF HEPARIN INFUSION VIA ALARIS PUMP AT 1900HRS, AT 2100 HRS, RN WENT TO THE PATIENT'S ROOM AND NOTICED THE IV BAG WAS COMPLETELY EMPTY. THE RATE AND VOLUME WAS CHECKED ON PUMP, THE NUMBERS WERE CORRECT, THE RATE WAS 9CCS/HR AND VOLUME TO BE INFUSED WAS 221MLS. ALARIS PUMP WAS USED ON (B)(6)2010 TO DELIVER HEPARIN. PATIENT LABS WAS MONITORED AND TREATED WITH PROTAMINE SULFATE. DATES OF USE: 2 HOURS, (B)(6)2010. DIAGNOSIS OR REASON FOR USE: POST CARDIAC CATHETERIZATION TREATMENT. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS ALARIS PC FRN CARE FUSION ALARIS PC T100130812950

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR