BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASSETTE MEDI RESERVOIR 12X100ML

    MDR report key: 13290079 · Received January 18, 2022

    Report

    Report Number
    MW5106770
    Event Type
    Malfunction
    Date Received
    January 18, 2022
    Report Date
    December 16, 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 CASSETTE LOT# 4192036 NO DISPOSABLE ALARM WHEN ATTACHED TO PUMP. PATIENT SWITCHED TO BACK UP PUMP, SAME ALARM RESULTED. PATIENT MIXED A NEW CASSETTE AND PUMP IS RUNNING FINE. NO SIGNIFICANT INTERRUPTIONS IN THERAPY, NO ADVERSE EVENTS RESULTED. 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 DEVICE AVAILABLE FOR INVESTIGATION? NO. DID WE [MFR] REPLACE CASSETTE? YES. DID THE PATIENT HAVE A ADDITIONAL CASSETTES THEY WERE ABLE TO SWITCH TO? YES. IF YES, WAS THE PATIENT ABLE TO SUCCESSFULLY CONTINUE THEIR INFUSION? YES. IS THE INFUSION LIFE-SUSTAINING? YES. WHAT IS THE OUTCOME OF THE EVENT? RESOLVED. RESOLVED? ONGOING? REPORTED TO (B)(6) BY: PATIENT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122720 CASSETTE MEDI RESERVOIR 12X100ML SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4192063

    Patients

    Seq Age Sex Outcome Treatment
    1 Female