BEUDAMED
    FDA Adverse Event Other Summary report: N

    Z-800 INFUSION PUMP

    MDR report key: 2270763 · Received September 26, 2011

    Report

    Report Number
    3006575795-2011-00028
    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 AND ALARM WERE WORKING PROPERLY WHEN ZYNO IV ADMINISTRATION SET WAS USED. THE USER FACILITY CONFIRMED TO ZYNO THAT THEY USED AN ADMINISTRATION SET MADE BY ANOTHER MANUFACTURER. ZYNO IMMEDIATELY INFORMED THE USER FACILITY TO STOP THIS PRACTICE. USING IV SETS OTHER THAN THE ONES MADE BY ZYNO MEDICAL VIOLATES WARNING PRINTED ON INSTRUCTIONS FOR USE AND THE PUMP LABEL. ZYNO MEDICAL REQUIRES THAT ONLY ZYNO IV ADMINISTRATION SETS BE USED WITH ZYNO PUMPS. TO NOTIFY OTHER CUSTOMERS OF THIS POTENTIAL ISSUE A CUSTOMER ADVISORY LETTER (DOCUMENT # (B)(4)) WAS SENT OUT, INDICATING 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 WAS UTILIZING NON-ZYNO IV SETS WITH ZYNO INFUSION PUMP. THIS VIOLATES ZYNO'S WARNING ("USE ONLY ZYNO IV SETS") PRINTED ON INSTRUCTIONS FOR USE AND LABEL AND ATTACHED TO THE PUMP. USING A ZYNO PUMP WITH ANY IV SET OTHER THAN 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