BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION, ENTERAL PRODUCT CODE: LZH

    MDR report key: 9537180 · Received January 1, 2020

    Report

    Report Number
    3012307300-2019-07562
    Event Type
    Malfunction
    Date Received
    January 1, 2020
    Date of Event
    December 2, 2019
    Report Date
    January 16, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LZH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B3, H6 INFORMATION WAS RECEIVED INDICATING THAT THE EVENT OCCURRED DURING USE AND INDICATED EVENT DATE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A CUSTOMER WITH A SMITHS MEDICAL CADD-LEGACY 1400 PUMP, INFORMED PSP THAT THE PATIENT HAS NEVER RECEIVED HIS MORNING DOSE (MD) OF DUODOPA BECAUSE SHE HAS HANDLED THE PUMP INCORRECTLY. THE WIFE HAS ONLY PRESSED THE MD BUTTON ONCE INSTEAD OF TWICE. ON THE (B)(6) 2019, SHE REALIZED THAT SHE WAS HANDLING THE PUMP INCORRECTLY WHEN THE PATIENT ACCIDENTALLY PUSHED THE BUTTON AGAIN IN THE AFTERNOON AND THE MD WAS ADMINISTERED. THE PATIENT BECAME HYPERKINETIC SO THEY HAD TO TURN OFF THE PUMP FOR A COUPLE OF HOURS UNTIL EVERYTHING WAS ALRIGHT TO CONTINUE THE TREATMENT. THE PATIENT PREVIOUSLY INCREASED THE MD DOSE FROM 9.0 ML TO 11.0ML TO 15.0 ML WITHOUT EFFECT. PSP HELPED THE WIFE TO UNLOCK THE PUMP AND DECREASE THE MD TO 9.0 ML AGAIN. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78 PUMP, INFUSION, ENTERAL PRODUCT CODE: LZH LZH SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1