BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP

    MDR report key: 15836934 · Received November 21, 2022

    Report

    Report Number
    3011581906-2022-00222
    Event Type
    Malfunction
    Date Received
    November 21, 2022
    Report Date
    November 21, 2022
    Manufacturer
    INFUTRONIX, LLC.
    Product Code
    FPA
    PMA / PMN Number
    K153193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INFUTRONIX IS WAITING FOR THE AFFECTED DEVICE TO BE RETURNED.

    Description of Event or Problem · 0

    INFUTRONIX SOLUTIONS RECEIVED A COMPLAINT FROM A HEALTHCARE PROFESSIONAL, WHO REPORTED ADMINISTRATION SET LEAKED DURING PATIENT INFUSION. AREA OF LEAK IS UNKNOWN. DEVICE OPERATOR WAS A NURSE. MEDICATION BEING INFUSED WAS 5FU. NO PATIENT INJURY REPORTED. 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
    1797170 ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP IV ADMINISTRATION SET FPA INFUTRONIX, LLC. HS-008-B 2106007

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown