BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP

    MDR report key: 7247344 · Received February 7, 2018

    Report

    Report Number
    3006575795-2018-00024
    Event Type
    Malfunction
    Date Received
    February 7, 2018
    Report Date
    January 31, 2018
    Manufacturer
    ZYNO MEDICAL LLC
    Product Code
    FPA
    UDI-DI
    00814371020075
    PMA / PMN Number
    K132841
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ZYNO MEDICAL RECEIVED AN INVESTIGATION REPORT FROM THE CONTRACT SUPPLIER OF THE AFFECTED DEVICE ON 01/29/2019. THE REPORTED "FILTER LEAK" COULD NOT BE CONFIRMED, BECAUSE THE ACTUAL DEVICE WAS NOT RETURNED FOR INVESTIGATION. THE SUPPLIER DETERMINED THAT THE REPORTED ISSUE WAS AN ISOLATED EVENT AFTER PERFORMING A REVIEW OF QN'S AND CUSTOMER COMPLAINTS FROM ONE YEAR PERIOD AND A REVIEW FOR DEVICES WITH FILTERS (LOT: 133761) FROM THE SAME LOT AS THE ONE ON THE AFFECTED DEVICE.

    Description of Event or Problem · 0

    THIS IS THE FOLLOW UP REPORT FOR THE INITIALLY SUBMITTED MDR (3006575795-2018-00024).

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE WAS NOT CAPTURED AT THE USER FACILITY, AND THUS ZYNO MEDICAL WAS UNABLE TO CONFIRM THE REPORTED ISSUE.

    Description of Event or Problem · 1

    A DISTRIBUTOR FORWARDED THE MESSAGE FROM A REPRESENTATIVE AT THE USER FACILITY REPORTING A FILTER LEAKING ISSUE TO ZYNO MEDICAL ON 01/31/2018. THE NURSE AT THE USER FACILITY FURTHER UPDATED THAT "WE HAVE BEEN HAVING SOME TROUBLE WITH THE FILTERS ON OR 80071-DF TUBING. THE FILTER MAKES A "SNAP" SOUND THE THEN STARTS LEAKING (YES, THE CLAMPS ARE OPEN!). A PATIENT ACTUALLY ALERTED THE NURSE SHE HEARD A "POP" AND THE NURSE INVESTIGATED AND FOUND CRACKED FILTER LEAKING. PT WAS NOT INJURED. THE SET WAS NOT SAVED BUT WILL SAVE ANY FUTURE ONES TO SEND BACK. UNCERTAIN OF EXACTLY WHICH PACKAGE THE MENTIONED TUBING CAME FROM." NO EVENT DATE WAS PROVIDED BY THE INITIAL REPORTER. THE CONTRACT SUPPLIER OF THE AFFECTED DEVICE IS BECTON DICKINSON. THE DISTRIBUTOR HAS CONFIRMED THAT THE MODEL NUMBER OF THE AFFECTED SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91173 ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP IV ADMINISTRATION SET FPA ZYNO MEDICAL LLC A2-80071-DF 17056528 00814371020075

    Patients

    Seq Age Sex Outcome Treatment
    1