BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYNO MEDICAL Z-800WF INFUSION PUMP SYSTEM

    MDR report key: 19786733 · Received July 20, 2024

    Report

    Report Number
    3006575795-2024-00549
    Event Type
    Injury
    Date Received
    July 20, 2024
    Date of Event
    July 10, 2024
    Report Date
    January 12, 2025
    Manufacturer
    ZYNO MEDICAL, LLC
    Product Code
    FRN
    PMA / PMN Number
    : K130690
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION OF THE RETURNED DEVICE WAS CONDUCTED, AND THE PUMP PASSED THE FLOW RATE TEST WITH A DEVIATION OF 1.58%. THE FAILURE MODE WAS NOT CONFIRMED. THE ROOT CAUSE REMAINS UNKNOWN, BUT BASED ON THE INVESTIGATION THE POTENTIAL ROOT CAUSES ARE 1. MIXED THE SOLUTION IN LESS VOLUME (HIGHER CONCENTRATION) THAN ANTICIPATED. 2. IV SET NOT PROPERLY INSTALLED IN PUMP BY HEALTHCARE PROVIDER. THIS INVESTIGATION IS ONGOING. REFERENCE COMPLAINT#: (B)(4).

    Additional Manufacturer Narrative · 0

    DEVICE RETURN REQUESTED. THERE ARE NO PREVIOUS COMPLAINTS ON THIS DEVICE. THE COMPLAINT WILL BE REOPENED AND UPDATED IN THE EVENT THE DEVICE INVOLVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE. A FOLLOW-UP MDR WILL BE SUBMITTED IN THE EVENT ADDITIONAL INFORMATION BECOMES AVAILABLE. A CAPA HAS BEEN OPENED IN ORDER TO FULLY INVESTIGATE AND ADDRESS THE ROOT CAUSE OF THE REPORTED EVENT. REFERENCE TO COMPLAINT #(B)(4).

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENT SERVES AS A CORRECTION. THE INCORRECT COMPLAINT NUMBER WAS INADVERTENTLY REPORTED, THE CORRECT COMPLIANT NUMBER IS: REFERENCE TO COMPLAINT # (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2024, DURING AN INFUSION, A PATIENT WAS SCHEDULED TO RECEIVE 250ML OF OXALIPLATIN OVER TWO HOURS. HOWEVER, THE INFUSION COMPLETED ONE HOUR EARLIER THAN PLANNED, DESPITE TWO NURSES REVIEWING THE PUMP PROGRAMMING BEFORE STARTING THE TREATMENT. NO HARM TO THE PATIENT OR USER HARM WAS REPORTED, AND THE PATIENT WAS SUBSEQUENTLY DISCHARGED HOME. ON (B)(6) 2024, THE PATIENT RETURNED TO THE HEALTHCARE CENTER FOR CHEMOTHERAPY DISCONNECTION AND PRESENTED WITH LEG SWELLING. THE NURSE ALERTED THE PROVIDER, AND THE PATIENT WAS PRESCRIBED LASIX. THE SYMPTOMS RESOLVED WITHOUT ANY SEQUELAE, AND THE PATIENT IS CURRENTLY STABLE.

    Description of Event or Problem · 0

    ON 07/10/2024, ZNYO MEDICAL RECEIVED A REPORT FROM THE CUSTOMER REPORTING THAT DURING AN INFUSION ON (B)(6) 2024, A PATIENT'S INFUSION WAS PROGRAMMED FOR A 2 HOUR INFUSION BUT THE INFUSION WAS COMPLETED IN 1 HOUR. CUSTOMER STATED THAT THE PROGRAMMING OF THE PUMP WAS REVIEWED BY 2 RN'S PRIOR TO STARTING THE INFUSIONS. NO HARM/INJURY TO THE PATIENT WAS REPORTED AT THAT TIME OF THE INCIDENT BUT THE PATIENT WAS SCHEDULED BACK TO RETURN ON (B)(6) 2024, TO ASSESS FOR FURTHER TOXICITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1500061 ZYNO MEDICAL Z-800WF INFUSION PUMP SYSTEM LARGE VOLUME INFUSION PUMP FRN ZYNO MEDICAL, LLC Z800WF 170412300

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention