BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS SECONDARY SET

    MDR report key: 7860054 · Received September 10, 2018

    Report

    Report Number
    9616066-2018-01558
    Event Type
    Injury
    Date Received
    September 10, 2018
    Date of Event
    July 31, 2018
    Report Date
    August 14, 2018
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    10885403234743
    PMA / PMN Number
    K790582
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 0.9% NORMAL SALINE AND A BAG OF LEVOFLOXACIN, THERAPY DATE (B)(6) 2018. NO PRODUCT WILL BE RETURNED AS THE ANONYMOUS CUSTOMER COULD NOT BE CONTACTED. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    RECEIVED A COPY OF THE FDA SUS VOLUNTARY EVENT REPORT WHICH STATES, "NURSE REPORTED THAT A NEW SECONDARY TUBING WAS PRIMED WITH 0.9% NORMAL SALINE AND A BAG OF LEVOFLOXACIN WAS SPIKED AND INITIATED INTO THE SECONDARY TUBING. THE PRIMARY TUBING WAS INFUSING WITH THE NORMAL SALINE. THE NURSE DISCOVERED SEDIMENT (PRECIPITATION), IN THE SECONDARY DRIP CHAMBER AND THE SECONDARY LINE WHEN LEVOFLOXACIN WAS INITIATED. NO PRECIPITATION WAS SEEN IN THE LEVOFLOXACIN BAG. THE RN TOOK DOWN DRUG BAG AND TUBING. A NEW BAG OF MEDICATION (SAME LOT EXPIRATION) AND SECONDARY TUBING (SAME LOT AND EXPIRATION) WERE USED AND THE PRECIPITATION DID NOT OCCUR. CONCOMITANT MEDICAL LEVOFLOXACIN 750MG /150 ML MG MILLIGRAM(S), MFR: CLARIS LIFE SCIENCES, DC # (B)(4), LOT # AOB0183, EXP: 01/31/2020, INTRAVENOUS DRIP." THERE WAS NO REPORT OF PATIENT HARM. THE REPORT LISTS PRODUCT PROBLEM, BUT "OTHER SERIOUS (IMPORTANT MEDICAL EVENTS)" IS CHECKED FOR ADVERSE EVENTS. SINCE THE REPORTER WAS ANONYMOUS NO FURTHER INFORMATION COULD BE OBTAINED REGARDING THE "OTHER SERIOUS" CLASSIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701425 ALARIS SECONDARY SET SET, SECONDARY, INTRAVASCULAR FPA CAREFUSION 11448964 18027055 10885403234743

    Patients

    Seq Age Sex Outcome Treatment
    1 Other PRI TUBING, THERAPY DATE (B)(6) 2018