BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNICELL I.V. STATION ONCO

    MDR report key: 11337085 · Received February 17, 2021

    Report

    Report Number
    3011278888-2021-00002
    Event Type
    Malfunction
    Date Received
    February 17, 2021
    Date of Event
    January 25, 2021
    Report Date
    May 26, 2021
    Manufacturer
    OMNICELL, INC.
    Product Code
    NEP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPAIR TECHNICIAN REVIEWED THE DEVICE AND CHECKED THE NEEDLE INSERTION AND DRUG PARAMETERS AND FOUND NO ISSUES THAT COULD HAVE CONTRIBUTED TO THE ALLEGED FAILURE. THE DEVICE WAS FURTHER REVIEWED AND DETERMINED THAT THE NEEDLE AND PINCHER WERE RELATIVELY OLD, AND THEREFORE NEED TO BE REPLACED. THE PARTS WERE ORDERED FOR THE REPAIR. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 0

    AS OF (B)(6) 2020, THE ESTABLISHMENT REGISTRATION AND LISTING FOR THE MANUFACTURER OF THIS DEVICE WAS UPDATED TO OMNICELL, INC. FROM AESYNT, INC, WHICH WAS NOT REFLECTED IN THE ORIGINAL REPORT SUBMISSION. ADDITIONALLY, AS OF (B)(6) 2021, THE ESTABLISHMENT REGISTRATION AND LISTING FOR THE CONTACT OFFICE OF THIS DEVICE WAS UPDATED FROM HEALTH ROBOTICS TO OMNICELL S.R.L, WHICH WAS NOT REFLECTED IN THE ORIGINAL REPORT SUBMISSION. THEREFORE, THIS REPORT IS A CORRECTION TO SECTIONS D3 AND G1.

    Additional Manufacturer Narrative · 1

    DUE TO THE ONGOING COVID-19 PANDEMIC, THE CUSTOMER HAS NOT PROVIDED ACCESS TO THE DEVICE TO BE EVALUATED BY THE MANUFACTURER. HISTORICAL RECORDS INDICATE THAT THIS DEVICE HAS MALFUNCTIONED SIMILARLY IN THE PAST, BUT A SINGULAR ROOT CAUSE CANNOT BE ASSIGNED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT MAY BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON DATE (B)(6), THE ONCO STATION HAD A SPILLAGE DURING MIXING OF DRUG PACLITAXEL. NO PATIENT OR USER IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235258 OMNICELL I.V. STATION ONCO PHARMACY COMPOUNDING DEVICE NEP OMNICELL, INC. I.V. STATION ONCO

    Patients

    Seq Age Sex Outcome Treatment
    1