BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP SYSTEM

    MDR report key: 10931499 · Received December 2, 2020

    Report

    Report Number
    3006575795-2020-00040
    Event Type
    Malfunction
    Date Received
    December 2, 2020
    Date of Event
    November 12, 2020
    Report Date
    February 8, 2021
    Manufacturer
    ZYNO MEDICAL, LLC
    Product Code
    FPA
    UDI-DI
    00814371020198
    PMA / PMN Number
    K132841
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONTRACT MANUFACTURER PROVIDED THE RESPONSE TO THE SCAR ON (B)(6) 2021. A REVIEW OF THE LAYOUT WAS PERFORMED FOR THE REPORTED MODEL B2-70072. THE LAYOUT HAS A FIXTURE WHICH WAS IMPLEMENTED IN (B)(6) 2019 TO AVOID THE "INVERTED PINCH CLAMP" FAILURE MODE. A POTENTIAL ROOT CAUSE IS THAT THE OPERATOR DID NOT FOLLOW THE ASSEMBLY SEQUENCE USING THE FIXTURE. A TREND REVIEW OF THE QNS (QUALITY NOTIFICATIONS) AND COMPLAINTS WERE PERFORMED IN A 1-YEAR PERIOD ((B0(6) 2020 TO (B)(6) 2021) FOR MODEL B2-70072. NO QNS OR ADDITIONAL COMPLAINTS RELATED TO THE FAILURE MODE WERE FOUND. THE COMPLAINT IS CONSIDERED AS AN ISOLATED CASE. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WERE PERFORMED. THE COMPLAINT WILL BE MONITORED FOR TRACK AND TREND.

    Description of Event or Problem · 0

    THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3006575795-2020-00040).

    Additional Manufacturer Narrative · 1

    ON 11/23/2020, ZYNO MEDICAL ISSUED (B)(4) TO THE CONTRACT MANUFACTURER TO ADDRESS THE REPORTED ISSUE. CURRENTLY, ZYNO MEDICAL IS WAITING FOR THE RESPONSE FROM THE CONTRACT MANUFACTURER.

    Description of Event or Problem · 1

    ON 11/13/2020, A DISTRIBUTOR OF ZYNO MEDICAL REPORTED A COMPLAINT. A USER FACILITY REPRESENTATIVE CONTACTED THE DISTRIBUTOR ON 11/12/2020, AND STATED THAT AN ADMINISTRATION SET MODEL#: B2-70072; LOT#: 20055819, HAD A PINCH CLAMP THAT WAS UPSIDE DOWN. NO PATIENT WAS INVOLVED. NO MEDICATION WAS BEING INFUSED. THE DEVICE OPERATOR WAS A REGISTERED NURSE. ON 11/23/3030, THE DISTRIBUTOR CONFIRMED THAT THE END-USER ONLY FOUND ONE ADMINISTRATION SET WITH THE INVERTED PINCH CLAMP IN THE ENTIRE CASE AND THAT THE AFFECTED ADMINISTRATION SET WILL NOT BE RETURNED. THE DISTRIBUTOR ALSO PROVIDED A PICTURE OF THE INVERTED PINCH CLAMP. ON 11/24/2020, THE DISTRIBUTOR PROVIDED TWO ADDITIONAL PICTURES OF THE AFFECTED SET. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS BECTON, DICKINSON AND COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1400061 ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP SYSTEM IV ADMINISTRATION SET FPA ZYNO MEDICAL, LLC B2-70072 20055819 00814371020198

    Patients

    Seq Age Sex Outcome Treatment
    1