BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM

    MDR report key: 6763619 · Received August 3, 2017

    Report

    Report Number
    3006575795-2017-00251
    Event Type
    Malfunction
    Date Received
    August 3, 2017
    Date of Event
    June 15, 2017
    Report Date
    September 15, 2017
    Manufacturer
    ZYNO MEDICAL LLC
    Product Code
    FRN
    UDI-DI
    00814371020006
    PMA / PMN Number
    K130690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER REPORTED OVER-INFUSING ISSUE WAS NOT CONFIRMED. THE DEVICE WAS FOUND TO HAVE A FLOW RATE ACCURACY OF -5.91%, WHICH WAS AN UNDER-INFUSING ISSUE AND WAS OUTSIDE OF THE +/-5% SPECIFICATION. THE DEVICE WAS ALSO FOUND TO HAVE A STIFF DOOR HINGE AND A NOISY MOTOR DURING INFUSION; NEITHER OF THESE ISSUES WAS RELATED TO THE REPORTED FLOW RATE ISSUE. THE PUMP WAS REPAIRED, RECALIBRATED, AND TESTED TO MEET ALL SPECIFICATION ON 09/06/2017.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS CURRENTLY WAITING FOR THE ARRIVAL OF THE DEVICE.

    Description of Event or Problem · 1

    THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2017-00251).

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE DEVICE HAD AN OVER-INFUSING ISSUE. THE CUSTOMER REPORTED "ZYNO Z-800 - SN: (B)(4) ORIGINAL CAME IN FOR ACCURACY, VOLUME INFUSES FASTER THAN PROGRAMMED TIME (BAG PROGRAMMED TO INFUSE OVER 1 HR AND IS EMPTY AFTER 30 MINUTES BUT A REMAINING VOLUME STILL REGISTERED ON THE PUMP. WE DID FIND THAT THE PUMP HAS ACCURACY ISSUES, THE DOOR HINGE IS BENT MAKING OPENING AND CLOSING THE DOOR DIFFICULT. WE ARE UNABLE TO REPAIR THIS PUMP DUE TO THE 12 TOOTH STRUCTURE OF THE PUMP'S MECHANISM. THIS PUMP NEEDS TO GO INTO THE MANUFACTURE FOR REPAIRS." NO PATIENT INJURY OR HARM OCCURED FOR THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544928 ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM LARGE VOLUME INFUSION PUMP FRN ZYNO MEDICAL LLC Z-800 20110516-SH 00814371020006

    Patients

    Seq Age Sex Outcome Treatment
    1