BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASSETTE MEDI RESERVOIR

    MDR report key: 13315312 · Received January 20, 2022

    Report

    Report Number
    MW5106864
    Event Type
    Malfunction
    Date Received
    January 20, 2022
    Report Date
    January 18, 2022
    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 - PATIENT REPORTED ANOTHER CASSETTE PROBLEM. LAST NIGHT THE PUMP WAS RUNNING AND SHE GOT THE DOUBLE WITH NO ERROR MESSAGE DISPLAYED. LIKE BEFORE, TRIED TO TAKE THE CASSETTE OFF AND RESTART AND STILL PROBLEM WON'T GO AWAY. THE ONLY WAY TO STOP IT IS BY CHANGING THE CASSETTES. LOT NUMBER 4192063. THIS IS DIFFERENT LOT NUMBER THAN BEFORE. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH A PATIENT? YES. DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PATIENT OR CLINICAL INJURY? NO. IS THE CASSETTE AVAILABLE TO BE RETURNED FOR INVESTIGATION? YES. WHAT IS THE OUTCOME OF THE EVENT? RESOLVED. DESCRIBE IN DETAIL ANY, AND ALL DAMAGE TO THE CASSETTE: NONE. HAS THIS INCIDENT HAPPENED WITHIN THE PAST 6 MONTHS? YES, OFFERED NURSING EVALUATION, PATIENT DECLINED. HAS THIS PATIENT REPORTED A PUMP MALFUNCTION WITHIN THE PAST 6 MONTHS? NO. IS 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. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1624067 CASSETTE MEDI RESERVOIR SET, I.V, FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4192063

    Patients

    Seq Age Sex Outcome Treatment
    1 Female