BEUDAMED
    FDA Adverse Event Other Summary report: N

    Z-800 INFUSION PUMP

    MDR report key: 2270786 · Received September 26, 2011

    Report

    Report Number
    3006575795-2011-00027
    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

    THOROUGH EVALUATION OF THE PUMP FOUND THAT THE AIR-IN-LINE SENSOR WAS WORKING PROPERLY AS DESIGNED WITH THE ZYNO IV ADMINISTRATION SET. THE USER FACILITY CONFIRMED THAT THE IV ADMINISTRATION SET USED WITH THE PUMP WAS NOT MADE BY ZYNO MEDICAL. ZYNO MEDICAL NOTIFIED THE USER FACILITY TO STOP THIS PRACTICE. USING IV SETS OTHER THAN ZYNO MEDICAL VIOLATES WARNINGS PRINTED ON INSTRUCTIONS FOR USE AND THE PUMP LABEL. ZYNO MEDICAL SPECIFIES THAT ONLY ZYNO IV ADMINISTRATION SETS BE USED WITH THEIR PUMPS. TO ADVISE OTHER CUSTOMERS OF THIS POTENTIAL ISSUE A CUSTOMER ADVISORY LETTER (DOCUMENT # (B)(4)) WAS SENT OUT, EXPLAINING 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 ADMINISTRATION SETS WITH ZYNO INFUSION PUMP. THESE ACTIONS VIOLATE THE ZYNO WARNING ("USE ONLY ZYNO IV SETS") PRINTED ON INSTRUCTIONS FOR USE AND LABEL AND ATTACHED TO THE PUMP. USING A ZYNO PUMP WITHOUT A ZYNO IV ADMINISTRATION SET INVALIDATES THE PUMP AS AN EFFECTIVE AND SAFE DEVICE. 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