BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASSETTE MEDI RESERVOIR

    MDR report key: 13472778 · Received February 4, 2022

    Report

    Report Number
    MW5107250
    Event Type
    Malfunction
    Date Received
    February 4, 2022
    Date of Event
    January 28, 2022
    Report Date
    January 28, 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

    SOLICITED CALL. SPOKE WITH PATIENT WHO STATED HE WAS ABLE TO SUCCESSFULLY CONTINUE HIS INFUSION USING A NEW CASSETTE WITH MORE NO ERRORS. PATIENT RESUMED AT PREVIOUS DOSE OF 30NG/KG/MIN AND PUMP RATE 32ML/24HR WITH NO ISSUES. INFORMED HIM TO CALL BACK IF HAVING ANY SIDE EFFECTS OR FURTHER PUMP ISSUES. CASSETTE LOT # 4163625. PATIENT USES CADD LEGACY PUMP. NO OTHER INFORMATION PROVIDED. 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 DEVICE AVAILABLE FOR INVESTIGATION? YES. DID WE (MFR) REPLACE THE DEVICE? 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
    1373566 CASSETTE MEDI RESERVOIR SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4163625

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male