BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASSETTE MEDI RESERVOIR

    MDR report key: 13783196 · Received March 15, 2022

    Report

    Report Number
    MW5108187
    Event Type
    Malfunction
    Date Received
    March 15, 2022
    Report Date
    March 14, 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: PT REPORTS CASSETTE MALFUNCTION (LOT: 4213379) NO DISPOSABLE, PUMP WILL NOT RUN. PHARMACY ADVISED PT NEEDS TO CALL PHARMACY RIGHT AWAY FOR ANY ERRORS OR ISSUE. PT UNDERSTANDS. NO DOSE DISTURBANCE. ALL KNOWN INFORMATION IS CONTAINED ON THIS FORM. IF ANY ADDITIONAL INFORMATION IS RECEIVED IT WILL BE PROVIDED ON A SEPARATE REPORT. CASSETTE NOT AVAILABLE FOR RETURN. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PT? YES; DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PT OR CLINICAL INJURY? NO; IS THE ACTUAL CASSETTE AVAILABLE FOR INVESTIGATION? NO; PT DISCARDED THE CASSETTE; DID WE [MFR] REPLACE THE CASSETTE? YES; 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 (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42551 CASSETTE MEDI RESERVOIR SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4213379

    Patients

    Seq Age Sex Outcome Treatment
    1 Female