BEUDAMED
    FDA Adverse Event Other Summary report: N

    Z-800 INFUSION PUMP

    MDR report key: 2270785 · Received September 26, 2011

    Report

    Report Number
    3006575795-2011-00025
    Event Type
    Other
    Date Received
    September 26, 2011
    Report Date
    August 22, 2011
    Manufacturer
    ZYNO MEDICAL LLC.
    Product Code
    FRN
    PMA / PMN Number
    K100705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE PUMP INDICATED THAT THE AIR-IN-LINE SENSOR FUNCTIONS PROPERLY WITH ZYNO IV ADMINISTRATION SET. THE IV SET USED WITH THE ZYNO INFUSION PUMP WAS NOT RETURNED, HOWEVER THE USER FACILITY CONFIRMED TO ZYNO THAT THEY WERE USING AN IV ADMINSTRATION SET THAT WAS MANUFACTURED BY ANOTHER MEDICAL DEVICE COMPANY, NOT BY ZYNO MEDICAL. ZYNO MEDICAL PROMPTLY NOTIFIED THE USER FACILITY TO STOP THIS PRACTICE. USING IV ADMINISTRATION SETS OTHER THAN THOSE MADE BY ZYNO MEDICAL VIOLATES WARNINGS PRINTED ON INSTRUCTIONS FOR USE AND THE PUMP LABEL. ZYNO MEDICAL CLEARLY INSTRUCTS USERS THAT ONLY ZYNO IV SETS SHOULD BE USED WITH ZYNO PUMPS. TO PREVENT OTHER CUSTOMERS FROM MAKING THE SAME MISTAKE, A CUSTOMER ADVISORY LETTER ((B)(4)) WAS SENT OUT TO ALL CUSTOMERS TO EMPHASIZE THAT THE PERFORMANCE TESTING FOR THE Z-800 PUMP WAS DONE ONLY WITH ZYNO PROPRIETARY IV SETS TO VALIDATE IT AS A SYSTEM. ANY USE OF NON-ZYNO IV SETS INVALIDATES THE PUMP AS AN EFFECTIVE AND SAFE SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP DID NOT ALARM "AIR IN LINE". USER FACILITY USED NON-ZYNO IV SETS WITH ZYNO INFUSION PUMP, DISREGARDING THE WARNING ("USE ONLY ZYNO IV SETS") PRINTED ON INSTRUCTIONS FOR USE AND LABEL ATTACHED TO THE PUMP. USE OF FOREIGN IV ADMINISTRATION SET INVALIDATES THE PUMP AS AN EFFECTIVE AND SAFE SYSTEM. ZYNO HAS REQUESTED BUT THE USER FACILITY HAS YET TO PROVIDE DETAILED INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Z-800 INFUSION PUMP LARGE VOLUME PERISTALTIC INFUSION PUMP FRN ZYNO MEDICAL LLC. Z-800 20090126

    Patients

    Seq Age Sex Outcome Treatment
    1 NI