BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASSETTE MEDI RESERVOIR

    MDR report key: 9511196 · Received December 20, 2019

    Report

    Report Number
    MW5091839
    Event Type
    Malfunction
    Date Received
    December 20, 2019
    Report Date
    December 12, 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

    SPONTANEOUS CALL FROM PATIENT STATING THAT BAGS IN CASSETTES ARE ¿TOO LARGE¿ (LOTS 3813605, 3834171 (PREVIOUSLY REPORTED) 3876357, 3876356) IN THE CASSETTE AND THAT IT IS DIFFICULT TO FIT ALL TIME MEDICATION/DILUENT IN THE CASSETTE. PATIENT IS ALSO STARTING THAT LOT 3876356 HAS SEDIMENT IN THE CASSETTE (VISIBLE PRIOR TO ADDING MEDICATION). PATIENT IS SAVING ALL FAULTY PRODUCTS. CASSETTE REPRESENTATIVE NOTIFIED. CNSS WILL FOLLOW-UP WITH PATIENT IN MORNING. NO FURTHER INFORMATION PROVIDED. DID THE PATIENT HAVE A BACKUP DEVICE THEY WERE ABLE TO SWITCH TO? YES. IF YES WAS THE PATIENT 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 THE PATIENT? NO. DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PATIENT OR CLINICAL INJURY? NO. DID WE REPLACE DEVICE? YES. REPORTED TO (B)(6) BY: PATIENT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1294981 CASSETTE MEDI RESERVOIR PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 3876356
    1294982 CASSETTE MEDI RESERVOIR PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1