BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGACY CASSETTE

    MDR report key: 13002681 · Received December 13, 2021

    Report

    Report Number
    MW5106035
    Event Type
    Malfunction
    Date Received
    December 13, 2021
    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 BOTH PUMPS ARE GIVING THE ERROR "NO DISPOSABLE PUMP WONT RUN, TWO TONE ALARM". ADVISED PT THAT ERROR SHOWS TO BE A CASSETTE NOT BEING ATTACHED CORRECTLY. BEFORE PT GOES AHEAD AND MAKES A NEW MIX CASSETTE, I ADVISED THAT HE CAN FOLLOW UP WITH NURSING SUPERVISOR. PATIENT AGREED AND IF NO ANSWERS THERE, HE WILL MAKE A NEW CASSETTE MIX UP. PT WAS ADVISED THAT OTHERWISE HE WILL NEED TO GO TO HOSPITAL, PATIENT UNDERSTOOD. CNSS (B)(6) FOLLOWED UP WITH PATIENT AND THEY CONCLUDED ISSUE WAS CASSETTE ERROR. PATIENT MADE A NEW MIX AND PUMP WAS RUNNING FINE. FAULTY CASSETTE LOT NUMBER 4163598. 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 PRODUCT AVAILABLE FOR INVESTIGATION? YES; DID WE [MFR] 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 THERAPY? YES; IS THE THERAPY LIFE-SUSTAINING? YES. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1886827 LEGACY CASSETTE SET, I.V, FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4163598

    Patients

    Seq Age Sex Outcome Treatment
    1 Male PUMP