BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP

    MDR report key: 8800413 · Received July 17, 2019

    Report

    Report Number
    3011581906-2019-00031
    Event Type
    Malfunction
    Date Received
    July 17, 2019
    Date of Event
    June 17, 2019
    Report Date
    July 5, 2019
    Manufacturer
    INFUTRONIX, LLC
    Product Code
    FPA
    UDI-DI
    00817170020024
    PMA / PMN Number
    K153193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED CASSETTE BACKWARDS ISSUE WAS CONFIRMED. THE PICTURE PROVIDED BY THE SERVICE PROVIDER SHOWED AN ADMINISTRATION SET WITH BACKWARDS CASSETTE. THE TUBING APPEARED TO BE INSTALLED BACKWARDS INTO THE CASSETTE, AS IF ROTATED 180 DEGREES FROM WHERE IT SHOULD BE. THE EVALUATION WAS COMPLETED ON 07/05/2019.

    Description of Event or Problem · 1

    ON 07/05/2019, A DISTRIBUTOR OF INFUTRONIX REPORTED A CASSETTE BACKWARDS ISSUE. THE DISTRIBUTOR RECEIVED AN ADMINISTRATION SET WITH A NOTE AND A PRINTED EMAIL FROM THE USER FACILITY. THE EMAIL STATED THE SET WAS FROM LOT # 1712004. THE NOTE STATED "MANUFACTURER DEFECT. GREEN CLAMP ON WRONG END OF THE CASSETTE." INSULINE AND NORMAL SALINE WERE THE MEDICATIONS BEING INFUSED. NO PATIENT INJURY OR HARM WAS REPORTED FOR THIS EVENT. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592957 ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP IV ADMINISTRATION SET FPA INFUTRONIX, LLC HS-003 1712004 00817170020024

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR