BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASSETTE MEDI RESERVOIR

    MDR report key: 13224259 · Received January 10, 2022

    Report

    Report Number
    MW5106563
    Event Type
    Malfunction
    Date Received
    January 10, 2022
    Report Date
    December 14, 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 DEFECTIVE CARTRIDGES AND DOES NOT HAVE ENOUGH FOR HIS NEXT MIX TOMORROW. LOT #2101979, EXP DATE 05/31/2022. NO ADD'L INFO AVAILABLE. 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? NO; DID WE [MFR] REPLACE THE PRODUCT? YES; DID THE PT HAVE A BACKUP PRODUCT THEY WERE ABLE TO SWITCH TO? YES; BUT BACKUP DID NOT WORK. 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
    1093107 CASSETTE MEDI RESERVOIR SET, I.V, FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 2101979

    Patients

    Seq Age Sex Outcome Treatment
    1 Male