BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEGACY ONE CADD PUMP

    MDR report key: 10733180 · Received October 23, 2020

    Report

    Report Number
    MW5097430
    Event Type
    Injury
    Date Received
    October 23, 2020
    Date of Event
    October 15, 2020
    Report Date
    October 20, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT HAS PUMP FOR INVESTIGATION. PHARMACY DID REPLACE PUMP. IS THE ACTUAL DEVICE AVAILABLE FOR INVESTIGATION? YES. DID WE REPLACE DEVICE? YES. DID THE PATIENT HAVE A BACK UP DEVICE THEY WERE 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. CAREGIVER STATES ON (B)(6) 2020 TO (B)(6) 2020 PATIENTS PUMP WAS NOT ON, THINKS PT MUST HAVE PRESSED THE OFF BUTTON WHILE SLEEPING, BUT THEY NOTICE DURING NEXT MIX THAT PUMP WAS OFF. THEY STATE THE PUMP KEEPS GIVING THEM AN ERROR SIGN (1260, 1261, LER-1210). THEY SWITCHED TO BACK UP PUMP. PATIENT HAS BEEN OFF MEDICATION FOR 2 DAYS. THEY THEN DID NOT CALL PHARMACY OR MD OFFICE. THEY RESTARTED THE INFUSION AT MAINTENANCE DOSE AND PT WAS EXPERIENCING SEVERE SIDE EFFECTS (SEVERE JAW PAIN, HEADACHES, NAUSEA, MUSCLE ACHES). RPH CONFIRMED WITH THE PATIENT NO SIDE EFFECT LAST 2 DAYS, THIS SITUATION WAS ADDRESSED AND WE DID SHIP PATIENT A NEW PUMP. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH A PATIENT? YES. DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PATIENT OR CLINICAL INJURY? YES, PATIENT WAS NOT FEELING WELL, SHE SWITCHED TO BACK UP PUMP. IF YES, WAS ANY MEDICAL INTERVENTION PROVIDED? UNKNOWN. REPORTED TO (B)(6) BY PATIENT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1195967 LEGACY ONE CADD PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 6400

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR