BEUDAMED
    FDA Adverse Event Other Summary report: N

    Z-800 INFUSION PUMP

    MDR report key: 2240608 · Received August 25, 2011

    Report

    Report Number
    3006575795-2011-00023
    Event Type
    Other
    Date Received
    August 25, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 24, 2011
    Manufacturer
    ZYNO MEDICAL LLC.
    Product Code
    FRN
    PMA / PMN Number
    K100705
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL OF THE RETURNED DEVICE INVOLVED IN THIS REPORT BY A ZYNO REPRESENTATIVE THAT THE AIR-IN-LINE SENSOR, FUNCTIONS PROPERLY WITH ZYNO IV SET. THE IV SET USED IN THIS INFUSION (RETURNED TOGETHER WITH THE PUMP, ATTACHED TO THE LEVOLEUCOVORIN CALCIUM BAG) WAS FOUND TO BE B. BRAUN IV SET ((B)(4)) WITH ZYNO INFUSION PUMP. ZYNO IMMEDIATELY REQUESTED THE USER FACILITY TO STOP THIS PRACTICE WHICH VIOLATES WARNINGS PRINTED ON INSTRUCTIONS FOR USE AND THE PUMP LABEL. ZYNO CLEARLY STATED THAT ONLY ZYNO IV SETS SHOULD BE USED WITH ZYNO PUMPS. ZYNO ALSO IMMEDIATELY DELIVERED A CASE OF ZYNO IV SETS FOR THE CUSTOMER TO USE. A FORMAL LETTER WAS SENT TO THE CUSTOMER TO EMPHASIZE THE IMPORTANCE OF USING ZYNO IV SETS. 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

    USER FACILITY USED NON-ZYNO IV SETS (B. BRAUN (B)(4)) WITH ZYNO INFUSION PUMP, DISREGARDING THE WARNING ("USE ONLY ZYNO IV SETS") PRINTED ON INSTRUCTIONS FOR USE AND LABEL ATTACHED TO THE PUMP. PUMP DID NOT ALARM "AIR IN LINE." USE FOR FOREIGN IV SET INVALIDATES THE PUMP AS AN EFFECTIVE AND SAFE SYSTEM. DETAILS: A REP FROM A DEVICE DISTRIBUTOR REPORTED THAT A PT RECEIVED A DOSE OF LEVOLEUCOVORIN OVER 2 HOURS ON (B)(6) 2011. THE PUMP WAS INFUSING AT A RATE OF 153 CC/HR. AT THE END OF THE INFUSION, THE MEDICATION COMPLETELY EMPTIED FROM THE BAG; HOWEVER, THE PUMP NEVER ALARMED, THERE WAS AIR IN TUBING AND CONTINUED TO RUN, COMPLETELY FILLING ENTIRE LENGTH OF TUBING WITH AIR. THE PT NOTIFIED THE NURSE THAT SHE DIDN'T SEE ANY MEDICATION DRIPPING IN THE CHAMBER. THE NURSE NOTED TUBING WAS COMPLETELY EMPTY TO PORT, PUMP WAS STILL INFUSING. AT THIS POINT THE NURSE CLAMPED TUBING, AND SHUT OFF THE PUMP. THE PT WAS ASSESSED AND TRANSFERRED VIA AMBULANCE TO THE EMERGENCY DEPARTMENT. ON (B)(6) 2011, THE REP REPORTED THE EVENT TO ZYNO AND CONFIRMED THAT THE PT WAS OK.

    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 20090910

    Patients

    Seq Age Sex Outcome Treatment
    1 NI