BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASSETTE MEDI RESERVOIR

    MDR report key: 14633287 · Received June 7, 2022

    Report

    Report Number
    MW5110198
    Event Type
    Malfunction
    Date Received
    June 7, 2022
    Report Date
    June 5, 2022
    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

    SPONTANEOUS. PATIENT REPORTS SHE WAS RECEIVING NO DISPENSABLE-PUMP WON'T RUN. PATIENT REPLACED CASSETTE AND PUMP BEGAN RUNNING AGAIN. LOT NUMBER OF CASSETTE 4052413. PATIENT DID NOT HAVE ANY INTERRUPTIONS TO THERAPY. PHOTOGRAPHS WERE NOT PROVIDED. SET FLOW RATE AND VOLUME DELIVERED ARE UNKNOWN. POSITION OF THE PUMP WHEN ALARM OCCURRED IS UNKNOWN. THIS IS A CONTINUOUS INFUSION. ALL KNOWN INFORMATION IS CONTAINED ON THIS FORM. IF ANY ADDITIONAL INFORMATION IS RECEIVED IT WILL BE PROVIDED ON A SEPARATE REPORT. 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 CASSETTE AVAILABLE FOR INVESTIGATION? YES; DID WE [MFR] REPLACE THE CASSETTE? NO; PT HAS ENOUGH ON HAND. DID THE PT HAVE ADD'L CASSETTES THEY WERE ABLE TO SWITCH TO? YES; IF YES, WAS THE PT ABLE TO SUCCESSFULLY CONTINUE THEIR INFUSION? YES; IS THE INFUSION 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
    26799 CASSETTE MEDI RESERVOIR SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. UNK 4052413

    Patients

    Seq Age Sex Outcome Treatment
    1 Female