BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURELY YOURS

    MDR report key: 4226664 · Received October 24, 2014

    Report

    Report Number
    3009974348-2014-00031
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    AMEDA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED TO AMEDA, INC AT THIS TIME. THE CUSTOMER OBSERVED "GREEN LIQUID" LEAKING OUT OF THE MOTOR AFTER SHE UNPLUGGED THE TUBING ADAPTER. IT WAS CONFIRMED THAT THE CUSTOMER WAS USING A MEDELA KIT WITH THE AMEDA PURELY YOURS BREAST PUMP. BASED ON THE CUSTOMER'S EVENT DESCRIPTION, THE LIQUID IS BREASTMILK THAT ENTERED THE PURELY YOURS BREAST PUMP. THE AMEDA PURELY YOURS INSTRUCTIONS FOR USE INDICATE THAT ONLY AMEDA APPROVED PARTS SHOULD BE USED WITH AMEDA PRODUCTS. THE REPORTED ISSUE WAS DUE TO USER ERROR.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED AMEDA VIA PHONE CALL ON (B)(6) 2014. SHE STATED THAT WHILE SINGLE PUMPING WITH A PURELY YOURS BREAST PUMP, THE TUBING ADAPTER BECAME DISCONNECTED AND BREAST MILK BACK-FLOWED INTO THE PUMP MOTOR. AFTER ATTEMPTING TO RESTART THE PUMP, SHE UNPLUGGED THE TUBING ADAPTER AND GREEN FLUID LEAKED OUT OF THE MOTOR. THE RECORD INDICATED THAT THE CUSTOMER STATED SHE USED ANOTHER MFR'S KIT WITH THE AMEDA PURELY YOURS PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679995 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA, INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1