BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS SECONDARY SET

    MDR report key: 18696418 · Received February 13, 2024

    Report

    Report Number
    9616066-2024-00224
    Event Type
    Malfunction
    Date Received
    February 13, 2024
    Date of Event
    January 22, 2024
    Report Date
    February 1, 2024
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    50885403222618
    PMA / PMN Number
    K790582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ALARIS SECONDARY SET WAS UNDER FUSING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: CEC ROUNDING ON 4 MAIN AND RN ASKED FOR HELP WITH INFUSING GLASS TYLENOL BOTTLE. RN STATED INFUSION WAS NOT RUNNING CORRECTLY. CEC ASSESSED INFUSION SET UP AND VISUALLY IT WAS CORRECT. CEC ASKED RN HOW INFUSION WAS INITIALLY PRIMED AS A SECONDARY MEDICATION. RN UNSURE AS HE DID NOT HANG OR PRIME MEDICATION. RN OBTAINED NEW SECONDARY INFUSION SET AND CHANGED TUBING. CEC PROVIDED EDUCATION ON PRIMING WITH A GLASS BOTTLE, BY FIRST SETTING GLASS BOTTLE ON COUNTER AND SPIKING BOTTLE, HANGING BOTTLE ON IV POLE AND FILLING THE DRIP CHAMBER 2/3 FULL BEFORE OPENING UP THE VENT CAP. RN RESTARTED INFUSION AND THE SECONDARY TYLENOL INFUSION CONTINUED TO RUN VERY SLOWLY. CEC CONTACTED (B)(6), CC (PREVIOUSLY VISITED SITE WITH CHANGE IN SECONDARY TUBING). (B)(6) STATED THAT TYLENOL NEEDS TO BE VENTED AND TO PROVIDE EDUCATION ON VENTING THE BOTTLE AFTER SPIKING FOR A FEW SECONDS, CLOSING THE VENT CAP AND THEN PROCEEDING TO FILL DRIP CHAMBER, OPEN VENT CAP AND PRIME TUBING. SHE ALSO SUGGESTED TO NOT BACKPRIME GLASS BOTTLE INFUSIONS. THIS EDUCATION WAS PROVIDED TO (B)(6), RN EDUCATOR FOR ALARIS AT UPMC (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2158694 BD ALARIS SECONDARY SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. UNKNOWN 50885403222618

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown