BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 1392696 · Received May 20, 2009

    Report

    Report Number
    2016493-2009-00051
    Event Type
    Other
    Date Received
    May 20, 2009
    Date of Event
    January 10, 2009
    Report Date
    April 6, 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
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PT INFO REQUESTED AND ALL AVAILABLE INFO IS INCLUDED. THIS REPORT WAS FILED BY THE MFR. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION; HOWEVER, THE SERIAL NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A F/U REPORT WILL BE SUBMITTED WITH ANY RELEVANT INFO.

    Description of Event or Problem · 1

    CUSTOMER REPORTED POTASSIUM 50MEQ/250ML (B)(4) HUNG AT 12:30 TO INFUSE OVER 5 HOURS. PUMP MODULE WAS PROGRAMMED 50ML/HOUR WITH 250ML TO INFUSE. AT APPROX 13:40, THE NURSE WENT INTO THE PT'S ROOM TO CHECK AN ALARMING PUMP AND FOUND THE POTASSIUM SECONDARY INFUSION EMPTY, THE BALANCE ON THE PUMP STILL READ APPROX 182ML. PHYSICIAN STAFF EVALUATED THE PT. THE PT HAD NO CARDIAC ARRHYTHMIAS OR DYSRYTHMIAS. EKG DONE AS ORDERED. THE PUMP WAS SET ASIDE SO, IT COULD BE CHECKED BY BIOMED. THE PUMP WAS FOUND TO HAVE A BROKEN DOOR AND IT HAD BEEN USED IN THAT CONDITION DURING THE REPORTED EVENT. THE PUMP WAS SENT TO THE BIOMED DEPT WHERE IT WAS REPAIRED, TESTED AND PUT BACK TO SERVICE. MULTIPLE ATTEMPTS TO CONTACT THE CLINICAL SOURCE FOR FURTHER PT AND EVENT INFO HAVE BEEN UNSUCCESSFUL. ALTHOUGH REQUESTED, NO ADD'L INFO WAS AVAILABLE. REVIEWED WITH CUSTOMER NEED TO CHECK THE DEVICE FOR ANY DAMAGE BEFORE USE AS INSTRUCTED IN THE DEVICE DIRECTIONS FOR USE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other ALARIS PC UNIT: SERIAL NUMBER UNK