BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASSETTE MEDI RESERVOIR

    MDR report key: 9800775 · Received March 5, 2020

    Report

    Report Number
    MW5093582
    Event Type
    Malfunction
    Date Received
    March 5, 2020
    Report Date
    March 2, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PER SPONTANEOUS EMAIL FROM FIELD NURSE (B)(6) - ONE OF PT'S CASSETTES WITH LOT NUMBER 3900380 WAS CAUSING A 'NON-DISPOSABLE CLAMP TUBING' ERROR ON PT'S CASSETTE. UPON INVESTIGATION, IT LOOKS LIKE THE SPRING IS TOO HIGH ON THE CASSETTE, CAUSING THE TUBING TO CLAMP, A NEW CASSETTE WAS MIXED AND PT CONTINUED INFUSION WITHOUT ISSUES WITH NEW CASSETTE. NO HARM TO PT. UNK IF THEY STILL HAVE DAMAGED CASSETTE FOR POSSIBLE RETURN IF NEEDED. IS THE INFUSION LIFE-SUSTAINING? YES. PICTURES ARE AVAILABLE IF NEEDED. WHAT IS THE OUTCOME OF THE EVENT? RESOLVED. REPORTED TO (B)(6) BY HEALTH-PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257460 CASSETTE MEDI RESERVOIR PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 3900380

    Patients

    Seq Age Sex Outcome Treatment
    1