BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP SYSTEM

    MDR report key: 10209695 · Received June 29, 2020

    Report

    Report Number
    3006575795-2020-00007
    Event Type
    Malfunction
    Date Received
    June 29, 2020
    Date of Event
    May 20, 2020
    Report Date
    September 3, 2020
    Manufacturer
    ZYNO MEDICAL, LLC
    Product Code
    FPA
    UDI-DI
    00814371020532
    PMA / PMN Number
    K132841
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONTRACT MANUFACTURER PROVIDED THE UPDATED INVESTIGATION REPORT ON 09/03/2020. THE CONTRACT MANUFACTURER HAVE THE FOLLOWING INSPECTIONS IN THEIR CURRENT PROCEDURE: 1. INSPECTION IN THE MOLDING PROCESS. 2. INSPECTION DURING THE WELDING OF SPIKE AIR INLET MEMBRANE IN THE ASSEMBLY PROCESS. 3. LIGHT INSPECTION OF THE DRIP CHAMBER ASSEMBLY. THE CONTRACT MANUFACTURER NOTIFIED THEIR EMPLOYEES ABOUT THE ISSUE OF THE COMPLAINT AND HAD REFRESHER TRAINING OF THE PROCEDURE ON 07/22/2020.

    Additional Manufacturer Narrative · 0

    THE CONTRACT MANUFACTURER PROVIDED THE INVESTIGATION REPORT ON (B)(6) 2020. THE POSSIBLE ROOT CAUSE HAS BEEN IDENTIFIED AS "THE SPIKE CONTACTS THE LUBRICANT OF THE INJECTION". CORRECTIVE ACTIONS TAKEN BY THE CONTRACT MANUFACTURER INCLUDE: INSPECTION IN THE MOLDING PROCESS INSPECTION DURING THE WELDING OF SPIKE AIR INLET MEMBRANE IN THE ASSEMBLY PROCESS LIGHT INSPECTION OF THE DRIP CHAMBER ASSEMBLY.

    Additional Manufacturer Narrative · 0

    THE SERVICE PROVIDER PERFORMED VISUAL INSPECTION OF THE DEFECTIVE ADMINISTRATION SET SAMPLE. THE REPORTED ISSUE WAS CONFIRMED.

    Description of Event or Problem · 0

    THIS IS THE THIRD MDR FOLLOW UP FOR THE INITIALLY FILED MDR (3006575795-2020-00007).

    Description of Event or Problem · 0

    THIS IS THE SECOND MDR FOLLOW UP FOR THE INITIALLY FILED MDR.

    Description of Event or Problem · 0

    THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2020-00007).

    Additional Manufacturer Narrative · 1

    ZYNO MEDICAL HAS ISSUED A SCAR (SCAR 2020-003) TO THE CONTRACT MANUFACTURER REGARDING THE COMPLAINT. USED SAMPLES RETURNED FROM THE CUSTOMER COULDN'T BE SENT TO THE CONTRACT MANUFACTURER DUE TO THE CUSTOM CONTROL IN (B)(6). THE SAMPLES WILL BE TESTED BY THE SERVICE PROVIDER. CURRENTLY, ZYNO MEDICAL IS WAITING FOR THE INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    ON (B)(6) 2020, A DISTRIBUTOR OF ZYNO MEDICAL REPORTED A COMPLAINT. A USER FACILITY REPRESENTATIVE CONTACTED THE DISTRIBUTOR ON (B)(6) 2020 STATING THAT "AN ADMINISTRATION SET MODEL BX-70071-D LOT 1709004 HAD A DIRTY SPIKE." NO PATIENT WAS INVOLVED. NO MEDICATION WAS USED. THE DEVICE OPERATOR WAS A NURSE PRACTITIONER. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS PODO XINGDA (TIANJIN) MEDICAL CO. LTD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670637 ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP SYSTEM IV ADMINISTRATION SET FPA ZYNO MEDICAL, LLC BX-70071-D 1709004 00814371020532

    Patients

    Seq Age Sex Outcome Treatment
    1