BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-CASSETTE MEDI RESERVOIR

    MDR report key: 17623856 · Received August 24, 2023

    Report

    Report Number
    MW5144944
    Event Type
    Malfunction
    Date Received
    August 24, 2023
    Report Date
    August 18, 2023
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PT REPORTS THEY WERE GETTING READY TO DOA CASSETTE CHANGE AND PT WAS ABOUT TO PRIME, BUT THE AREA WHERE THE RED CAP IS/WAS CRACKED AND THE CASSETTE (LOT NUMBER 943148) BECAME UNUSABLE, SO THEY HAD TO WASTE IT. PT REPORTS THEY HAVE 2 MORE CASSETTES ON HAND. IV REMODULIN PREMIX PT. NO ADDITIONAL INFO, DETAILS, OR DATES AVAILABLE. THIS IS A CONTINUOUS INFUSION. SET FLOW RATE AND VOLUME DELIVERED ARE UNKNOWN. POSITION OF THE PUMP WHEN ALARM OCCURRED IS NOT APPLICABLE AS NO PUMP ALARM WAS REPORTED. PUMP RETURN TRACKING INFORMATION IS NOT APPLICABLE AS NO PUMP ISSUE WAS REPORTED. PHOTOGRAPHS WERE NOT PROVIDED. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PT? NO. DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PT OR CLINICAL INJURY? NO. IS THE ACTUAL PRODUCT AVAILABLE FOR INVESTIGATION? YES. DID THE PHARMACY REPLACE THE PRODUCT? YES. DID THE PT HAVE A BACKUP PRODUCT THEY WERE ABLE TO SWITCH TO? YES. WAS THE PT ABLE TO SUCCESSFULLY CONTINUE THEIR INFUSION? YES. IS THE THERAPY LIFE SUSTAINING? YES. WHAT IS THE OUTCOME OF THE EVENT? RESOLVED. REPORTED TO CVS/CAREMARK BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1434885 C-CASSETTE MEDI RESERVOIR SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. UNK 943148

    Patients

    Seq Age Sex Outcome Treatment
    1 Female