BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD PUMP LEGACY

    MDR report key: 16068093 · Received December 28, 2022

    Report

    Report Number
    MW5114058
    Event Type
    Malfunction
    Date Received
    December 28, 2022
    Report Date
    December 16, 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

    THE PATIENT REPORTED SHE HAS BEEN EXPERIENCING ISSUES WITH HER CADD CASSETTES AND PUMP REQUIRING OCCASIONAL RESTARTS. CADD CASSETTE LOT NUMBER 4329614 AND EXPIRATION DATE 09/18/2027. PUMP SERIAL NUMBER/DUE DATE UNKNOWN. NO ADDITIONAL INFORMATION, DETAILS OR DATES ARE AVAILABLE AT THIS TIME. RETURN TRACKING INFORMATION IS NOT AVAILABLE. PHOTOGRAPHS WERE NOT PROVIDED THIS IS A CONTINUOUS INFUSION. SET FLOW RATE AND VOLUME DELIVERED ARE UNKNOWN. POSITION OF THE PUMP WHEN EVENT OCCURRED IS UNKNOWN. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PT? UNK; DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PT OR CLINICAL INJURY? UNK; IS THE ACTUAL PRODUCT AVAILABLE FOR INVESTIGATION? UNK; DID WE [MFR] REPLACE THE PRODUCT? YES; DID THE PT HAVE A BACKUP PRODUCT THEY WERE ABLE TO SWITCH TO? UNK. WAS THE PT ABLE TO SUCCESSFULLY CONTINUE THEIR THERAPY? YES; REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524006 CADD PUMP LEGACY PUMP, INFUSION LHI SMITHS MEDICAL ASD, INC. 6400
    524007 CASSETTE MEDI RESERVOIR SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4329614

    Patients

    Seq Age Sex Outcome Treatment
    1 Female REMODULIN