BEUDAMED
    FDA Adverse Event Other Summary report: N

    Z-800 INFUSION PUMP

    MDR report key: 2270774 · Received September 26, 2011

    Report

    Report Number
    3006575795-2011-00026
    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 DETERMINED THAT THE AIR-IN-LINE SENSOR FUNCTIONS PROPERLY AS DESIGNED WITH THE ZYNO IV ADMINISTRATION SET. THE AIR-IN-LINE SENSOR AND ALARM WAS THOROUGHLY TESTED 100 TIMES AND ALL TESTS PASSED. THE USER FACILITY CONFIRMED TO ZYNO THAT THEY USED AN ADMINISTRATION SET THAT WAS NOT MANUFACTURED BY ZYNO MEDICAL. ZYNO MEDICAL IMMEDIATELY NOTIFIED THE USER FACILITY TO STOP THIS PRACTICE. USING IV SETS OTHER THAN THE ZYNO MEDICAL IV ADMINISTRATION SET VIOLATES WARNING PRINTED ON INSTRUCTIONS FOR USE AND THE PUMP LABEL. ZYNO MEDICAL CLEARLY SPECIFIES TO USERS THAT ONLY ZYNO IV SETS SHOULD BE USED WITH ZYNO PUMPS. TO ALERT OTHER CUSTOMERS OF THIS POTENTIAL ISSUE A CUSTOMER ADVISORY LETTER ((B)(4)) WAS SENT OUT TO ALL CUSTOMERS DETAILING 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

    USER FACILITY USED NON-ZYNO IV ADMINISTRATION SETS WITH ZYNO INFUSION PUMP. THIS ACTIVITY VIOLATES THE ZYNO WARNING ("USE ONLY ZYNO IV SETS") PRINTED ON INSTRUCTIONS FOR USE AND LABEL AND ATTACHED TO THE PUMP. PUMP DID NOT ALARM "AIR IN LINE". USE OF THIS NON ZYNO IV ADMINISTRATION SET INVALIDATES PUMP WARRANTY 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