BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASSETTE MEDI RESERVOIR

    MDR report key: 9362895 · Received November 21, 2019

    Report

    Report Number
    MW5091245
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Report Date
    November 13, 2019
    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

    PT REPORTED FAULTY CASSETTES, THEY ALL HAVE BAGS THAT ARE LARGER THAN THE CASSETTE ITSELF AND SOME OF THEM HAVE SPECS IN THE BAG. SHE IS AVOIDING THOSE, BUT USING THE OTHER BAGS WITHOUT SPECS THAT ARE STILL TOO LARGE FOR THE CASSETTE. THE LOT NUMBERS ARE 3876356, 3834171, AND 3813603. NO INJURY AS RESULT. PT WASTED CASSETTES THOUGH. PT MAY HAVE AVAILABLE TO RESEND BACK TO SMITH MEDICAL. NO INTERRUPTION IN INFUSION. DID THE PT HAVE A BACKUP DEVICE 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? ONGOING? RESOLVED. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH A PT? NO. DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PT OR CLINICAL INJURY? NO. IS THE ACTUAL DEVICE AVAILABLE TO BE RETURNED FOR INVESTIGATION? PT MAY HAVE CASSETTES AVAILABLE TO RETURN. DID WE REPLACE THE DEVICE? YES. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1153675 CASSETTE MEDI RESERVOIR PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC.
    1153676 CASSETTE MEDI RESERVOIR PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC.
    1153677 CASSETTE MEDI RESERVOIR PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1