BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASSETTE MEDI RESERVOIR

    MDR report key: 13283197 · Received January 14, 2022

    Report

    Report Number
    MW5106709
    Event Type
    Malfunction
    Date Received
    January 14, 2022
    Report Date
    December 18, 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 CALL FROM PATIENT TO REPORT BOTH PUMPS WERE SHOWING NO DISPOSABLE FOUND. SHE CHANGED OUT THE CASSETTE AND BOTH PUMP WORKING FINE. CASSETTE LOT NUMBER IS 4192063. NO ADDITIONAL INFORMATION OR DATES REPORTED. 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 CASSETTE AVAILABLE FOR INVESTIGATION? YES. DID WE [MFR] REPLACE THE CASSETTE? NO; PT HAD ADD'L. DID THE PT HAVE ADD'L CASSETTES THEY WERE ABLE TO SWITCH TO? YES; IF YES, WAS THE PT ABLE TO SUCCESSFULLY CONTINUE THEIR INFUSION? YES; IS THE INFUSION LIFE-SUSTAINING? YES; WHAT IS THE OUTCOME OF THE EVENT? RESOLVED. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164143 CASSETTE MEDI RESERVOIR SET, I.V, FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4192063

    Patients

    Seq Age Sex Outcome Treatment
    1 Female