BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP SYSTEM

    MDR report key: 10209694 · Received June 29, 2020

    Report

    Report Number
    3006575795-2020-00005
    Event Type
    Malfunction
    Date Received
    June 29, 2020
    Date of Event
    May 29, 2020
    Report Date
    August 7, 2020
    Manufacturer
    ZYNO MEDICAL, LLC
    Product Code
    FPA
    UDI-DI
    00814371020457
    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 INVESTIGATION REPORT ON 08/07/2020. THE ADMINISTRATION SETS THAT THE CUSTOMER USED WERE MANUFACTURED IN 2017. THE SAME LEAKING ISSUE AT THE NEEDLESS INJECTION SITE (THE SMART SITE) WAS OBSERVED BACK IN 2017. THE SUPPLIER OF THE SMART SITE PERFORMED THE INVESTIGATION AND CONCLUDED THAT THE DEFORMATION OF THE COMPONENT WAS DUE TO EXCESSIVE HEAT EXPOSURE DURING TRANSPORTATION AND/OR STORAGE AFTER LEAVING THE MANUFACTURING FACILITY. IT WAS NOT BELIEVED TO BE A MOLDING OR ASSEMBLY RELATED DEFECT DURING THE MANUFACTURING PROCESS. SINCE ON (B)(6) 2017, THE CONTRACT MANUFACTURER STARTED TO IMPLEMENT 100% VISUAL INSPECTION OF THE SMART SITES AND PERFORM THE PRESSURE TESTS FOLLOWING THE SOP. NO SIMILAR DEFORMATION PROBLEM HAS BEEN FOUND SINCE THEN. IN ADDITION, THE EXPIRATION DATE OF THE ADMINISTRATION SETS IS 05/03/2020. THE EVENT DATE WAS ON (B)(6) 2020. THE ADMINISTRATION SETS THAT THE END CUSTOMER USED HAVE PASSED THE EXPIRATION DATE.

    Additional Manufacturer Narrative · 0

    CUSTOMER RETURNED ADMINISTRATION SET HAS BEEN TESTED BY THE SERVICE PROVIDER. NO LEAKING WAS OBSERVED FROM THE FILTER. THE CUSTOMER REPORTED ISSUE CANNOT BE REPEATED. THE COMPLAINT CANNOT BE CONFIRMED. LEAKING WAS OBSERVED FROM THE NEEDLESS INJECTION SITE. THE INVESTIGATION REPORT WAS PROVIDED TO THE CONTRACT MANUFACTURER ON 07/20/2020. CURRENTLY, ZYNO MEDICAL IS WAITING FOR THE RESULTS OF THE RELATED SCAR (SCAR 2020-003).

    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 (3006575795-2020-00005).

    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 AX-80071-DF LOT 1705004 SET WAS LEAKING AT THE FILTER." A PATIENT WAS INVOLVED, BUT WAS NOT HARMED OR INJURED. THE DEVICE OPERATOR WAS A REGISTERED NURSE. MEDICATION INFUSED WAS KADCYLA. 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
    670636 ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP SYSTEM IV ADMINISTRATION SET FPA ZYNO MEDICAL, LLC AX-80071-DF 1705004 00814371020457

    Patients

    Seq Age Sex Outcome Treatment
    1