BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASSETTE MEDI RESERVOIR

    MDR report key: 12682366 · Received October 21, 2021

    Report

    Report Number
    MW5104894
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Report Date
    July 28, 2021
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SPONTANEOUS. PT'S MOTHER REPORTED DEFECTIVE CASSETTE AND A SPIKE WITH A BROKEN AIR FILTER. NEITHER ITEM WERE USED BY THE PATIENT. NO ADVERSE EVENT REPORTED. ITEMS ARE NOT AVAILABLE FOR INVESTIGATION. CASSETTE LOT NUMBER 4120063. NO FURTHER DETAILS PROVIDED. 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 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; WAS THE PT ABLE TO SUCCESSFULLY CONTINUE THEIR INFUSION? YES; IS THE INFUSION LIFE-SUSTAINING? YES. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1572350 CASSETTE MEDI RESERVOIR SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4120063
    1572351 SPIKE WITH FILTER SET, I.V. FLUID TRANSFER LHI UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1