BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTEZ 100 ML, 200 ML / HR

    MDR report key: 8191365 · Received December 20, 2018

    Report

    Report Number
    MW5082497
    Event Type
    Malfunction
    Date Received
    December 20, 2018
    Date of Event
    December 17, 2018
    Report Date
    December 18, 2018
    Manufacturer
    EPIC INTERNATIONAL (THAILAND) CO., LTD. / REGISTRAR CORP.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT CALLED ON-CALL RN TO REPORT HIS DAPTOMYCIN 600 MG / NS 100 ML [SE0200-100] NOT INFUSING AND STATED THAT HE HAS BEEN CONNECTED FOR 45 MIN AND THE BALL HAS NOT GOTTEN ANY SMALLER. IT WAS SUPPOSED TO RUN FOR 30 MIN. ON-CALL RN INSTRUCTED PT TO DISCONNECT THE TUBING FROM THE PICC, BEING CAREFUL NOT TO TOUCH THE TIPS TO SEE IF THERE IS ANY MEDICATION DRIPPING. HE REPORTED TO ON-CALL RN THAT THE MEDICATION WAS DRIPPING. ON-CALL RN INSTRUCTED HIM / HIS WIFE TO FLUSH AGAIN WITH SALINE, THEN RECONNECT THE MEDICATION AND ALLOW TO INFUSE AGAIN. PT INSTRUCTED TO CALL ON-CALL RN IF DOSE DOES NOT INFUSE. NO RETURN CALL FROM PT TO ON-CALL RN. LOT UNK; DEVICE NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027460 SMARTEZ 100 ML, 200 ML / HR PUMP, INFUSION, ELASTOMERIC MEB EPIC INTERNATIONAL (THAILAND) CO., LTD. / REGISTRAR CORP. SE0200-100

    Patients

    Seq Age Sex Outcome Treatment
    1