BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASSETTE MEDI RESERVOIR

    MDR report key: 12662615 · Received October 18, 2021

    Report

    Report Number
    MW5104751
    Event Type
    Malfunction
    Date Received
    October 18, 2021
    Date of Event
    May 8, 2021
    Report Date
    May 8, 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

    SPONTANEOUSLY PT CALLED TO REPORT THAT BOTH PUMPS ARE ALARMING FOR "NO DISPOSABLE"; ADVISED PT TO MAKE NEW MILL AND USE DIFFERENT LOT CASSETTE AS MOST LIKELY THE PROBLEM IS WITH THE CASSETTE, NOT PUMPS. PT FOLLOWED MY ADVICE AND MADE NEW MILL WITH NEW CASSETTE FROM NEW LOT; INFUSION RESTARTED WITHOUT AN ISSUE; CASSETTE LOT: 4052413. THERE IS NO PROBLEM WITH PUMP. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PATIENT? YES, DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PATIENT OR CLINICAL INJURY? NO, IS THE ACTUAL CASSETTE AVAILABLE FOR INVESTIGATION? NO, DID WE REPLACE CASSETTE? NO, DID THE PATIENT HAVE BACKUPS THEY WERE ABLE TO SWITCH TO? YES, WAS THE PATIENT 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
    1550175 CASSETTE MEDI RESERVOIR SET, I.V, FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. UNK 4052413

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR