BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP

    MDR report key: 6725213 · Received July 19, 2017

    Report

    Report Number
    3006575795-2017-00244
    Event Type
    Malfunction
    Date Received
    July 19, 2017
    Date of Event
    July 3, 2017
    Report Date
    July 18, 2017
    Manufacturer
    ZYNO MEDICAL LLC
    Product Code
    FPA
    UDI-DI
    00814371020600
    PMA / PMN Number
    K132841
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER REPORTED LEAKING ISSUE WAS CONFIRMED. ZYNO MEDICAL HAS RECEIVED THE INVESTIGATION REPORT FROM THE CONTRACT SUPPLIER AMSINO INTERNATIONAL, INC ON 01/12/2018. THE ROOT CAUSE OF ISSUE IS FOUND TO BE THE DEFORMATION OF THE ROLLER OCCURED DURING THE ASSEMBLING PROCESS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2017-00244).

    Description of Event or Problem · 1

    ON (B)(6) THE USER REPORTED FLUID LEAKING ISSUE WITH ADMINISTRATION SETS. "WE HAVE HAD SEVERAL MORE CASES OF THIS SAME PROBLEM. WE KEPT ONE OF THE TUBING SETS. UNFORTUNATELY THE OTHER ONE WAS CONTAMINATED WITH HAZARDOUS DRUG AND WE HAD TO DISPOSE OF IT." THE NURSE USED 1000ML IVPB NORMAL SALINE, AND (B)(6)2017 WAS THE DATE THAT THE IVPB MADE IT TO THE NURSE. "TECHNICALLY THE PATIENT WAS NOT INVOLVED. THE MEDIATION WAS MADE AND SENT TO THE NURSE. BEFORE ADMINISTERING THE MEDICATION SHE NOTICED THAT FLUID WAS LEAKING INTO THE CHEMO BAG THAT CONTAINED THE IVPB. IT WAS NOTICED THAT THE CLAMP WAS CLOSED AND FLUID WAS STILL LEAKING. WE HAVE ALSO HAD THIS HAPPEN ON SEVERAL OCCASIONS WHEN WE SPIKE THE BAG BEFORE MEDICATION IS ADDED." NO PATIENT INJURY OR HARM OCCURRED FOR THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505591 ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP IV ADMINISTRATION SET FPA ZYNO MEDICAL LLC AA-80075 109233KS 00814371020600

    Patients

    Seq Age Sex Outcome Treatment
    1