BEUDAMED
    FDA Adverse Event Other Summary report: N

    SET, ADMINISTRATION

    MDR report key: 1278385 · Received December 24, 2008

    Report

    Report Number
    9616066-2008-00136
    Event Type
    Other
    Date Received
    December 24, 2008
    Report Date
    December 15, 2008
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    FPA
    PMA / PMN Number
    K022209
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). THIS REPORT WAS FILED BY THE MANUFACTURER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED NURSE HUNG A SECONDARY INFUSION OF POTASSIUM 20 MEQ AND THE PRIMARY WAS INFUSING AT 66 ML/HR. SHE DID NOT SET UP THE PUMP AS A SECONDARY INFUSION. SHE RAISED THE SECONDARY INFUSION AND LOWERED THE PRIMARY AND SAW THAT IT WAS RUNNING. SHE THEN NOTICED WITHIN 5 MINUTES THAT THE SECONDARY BAG APPEARED TO BE FREE FLOWING. SHE DID NOT KNOW WHERE THE SECONDARY WENT. SHE STARTED A NEW PRIMARY AND SECONDARY INFUSION ON A DIFFERENT PUMP. DATE OF EVENT NOT REPORTED. THE SETS AND BAGS WERE DISCARDED. THE PUMP WAS SENT TO BIOMED. BIOMED REPORTED THE PUMP WAS TESTED FOR RATE ACCURACY AND WAS WORKING AS DESIGNED. THE PUMP WAS PLACED BACK IN USE AFTER TESTING. NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SET, ADMINISTRATION FPA CARDINAL HEALTH ALARIS PRODUCTS 72002N UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other PRIMARY SET MODEL #2420-0500