BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEO 90 INFUSION SET

    MDR report key: 17949562 · Received October 16, 2023

    Report

    Report Number
    MW5146998
    Event Type
    Injury
    Date Received
    October 16, 2023
    Date of Event
    October 10, 2023
    Report Date
    October 11, 2023
    Manufacturer
    SMITHS MEDICAL ASD INC.
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PER CNSS COMMUNICATION: "DATE OF VISIT: (B)(6) 2023. ADVERSE EVENT EXPERIENCED: NAUSEA, VOMITING, AND FLUSHING, TUBING LEAKS. DESCRIPTION OF EVENT(S): EPISODES OF VOMITING, NAUSEA, AND FLUSHING. ADVERSE EVEN START DATE (PER REPORTER): (B)(6) 2023. ADVERSE EVENT RESOLUTION DATE: ONGOING. COMMENTS: PT REPORTS THAT HER CURRENT TUBING FOR HER MS3 HAS BEEN LEAKING. SHE HAS BEEN EXPERIENCING SIDE EFFECTS INCLUDING NAUSEA, VOMITING, AND FLUSHING. BECAUSE OF THIS, SHE REDUCED HER DOSE FROM 0.052ML/HR TO 0.024ML/HR. MD OFFICE AWARE. I SPOKE WITH RN (B)(6) AT THE MD OFFICE AND SHE SAYS PT WILL BE STAYING AT THIS LOWER DOSE, THEN TITRATING ONCE SIDE EFFECTS SUBSIDE BACK TO GOAL DOSE. I HAVE REQUESTED NEW TITRATION ORDERS FROM THE MD OFFICE." NO FURTHER INFO, DETAILS OR DATES AVAILABLE. LOT NUMBER OF LEAKING TUBING IS UNKNOWN SQ REMODULIN MS3 PT UNIQUE ID IS NOT AVAILABLE, RECORD WILL BE RESUBMITTED ONCE ID IS AVAILABLE. REPORTED TO CVS/CAREMARK BY: HEALTH PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66193 CLEO 90 INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female AMBRISENTAN.| REMODULIN MDV.| REMODULIN.