BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTEZ PUMP

    MDR report key: 7850289 · Received September 6, 2018

    Report

    Report Number
    7850289
    Event Type
    Malfunction
    Date Received
    September 6, 2018
    Date of Event
    August 10, 2018
    Report Date
    August 22, 2018
    Manufacturer
    EPIC INTERNATIONAL CO, LTD. (REGISTRAR CORP)
    Product Code
    MEB
    UDI-DI
    28859299101013
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ADMIXTURE CENTER DISCOVERED MULTIPLE SMARTEZ DEVICES LEAKED AFTER THE PREPARATION OF 3 GRAMS OF A DRUG IN 0.9% NACL 100 ML VOLUME. ON CLOSER INVESTIGATION, WE NOTICED A CRACK AT THE FILL PORT. THE LEAKING DEVICES WERE NOT DISPENSED TO THE PATIENT ON ALL DEVICES WHEN THE PROBLEMS WERE DISCOVERED. AFTER REVIEW WITH MEDICATION SAFETY, THE REMAINING UNFILLED DEVICES FROM THIS LOT NUMBER S7L21 WERE REMOVED FROM OUR ACTIVE STOCK AND SEQUESTERED. THE 156 DEVICES REMAIN SEQUESTERED AND ARE UNABLE TO BE UTILIZED. THIS DID NOT NEGATIVELY IMPACT ANY PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692087 SMARTEZ PUMP PUMP, INFUSION, ELASTOMERIC MEB EPIC INTERNATIONAL CO, LTD. (REGISTRAR CORP) 481012 S7L21 28859299101013

    Patients

    Seq Age Sex Outcome Treatment
    1