BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASSETTE MEDI RESERVOIR

    MDR report key: 13591872 · Received February 23, 2022

    Report

    Report Number
    MW5107654
    Event Type
    Malfunction
    Date Received
    February 23, 2022
    Report Date
    February 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 CALL: CASSETTE MALFUNCTION: LOT#:416-3625, ERROR "NO DISPOSABLE LINE" PATIENT STATES THAT SAME ERROR HAPPENED TO HER BACK UP PUMP AS WELL. BUT SHE DID A NEW CASSETTE, AND SHE IS INFUSING MEDICATION WITH NO ISSUE. PATIENT CURRENTLY HAS #7 CASSETTE AND SHE WILL CALL BACK MONDAY TO DO A WEEKLY REFILL FOR HER DME/ DILUENT. DID THE REPORTED PRODUCT FAUT 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? YES; 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
    1863082 CASSETTE MEDI RESERVOIR SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 416-3625

    Patients

    Seq Age Sex Outcome Treatment
    1 Female