BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICK SET PARADIGM

    MDR report key: 2761674 · Received September 17, 2012

    Report

    Report Number
    3003442380-2012-00016
    Event Type
    Death
    Date Received
    September 17, 2012
    Date of Event
    September 8, 2012
    Report Date
    September 17, 2012
    Manufacturer
    UNOMEDICAL DEVICE S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K011071
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO USED OR UNUSED DEVICES WERE RETURNED TO MANUFACTURER WHICH PREVENTED US FROM TESTING. SINCE THE LOT NUMBER IS UNK, NO BATCH RECORD COULD BE REVIEWED OR TESTING OF RETAINED SAMPLES COULD BE PERFORMED. IF THE LOT NUMBER BECOMES AVAILABLE, THE CASE WILL BE RE-OPENED AND APPROPRIATE ACTIONS WILL BE TAKEN. ACCORDING TO COMPLAINT DESCRIPTION THE CAUSE OF DEATH WAS A KIDNEY FAILURE DUE TO CUSTOMER NOT BEING IN COMPLIANCE WITH HER TREATMENT/DIALYSIS, STATED THAT CUSTOMER STOPPED GOING TO DIALYSIS BECAUSE SHE WAS TIRED.

    Description of Event or Problem · 1

    AWARE DATE: (B)(6) 2012. DOCUMENT RESPONSE: DR. (B)(6), BUT A YEAR AGO HE STOPPED BEING HER HCP BECAUSE HE WAS A KIDNEY DOCTOR, SINCE THE CUSTOMER'S KIDNEYS WERE FAILING. CALLER'S RELATIONSHIP TO THE DECEASED: HUSBAND. DETAILS OF THE EVENT: "WHAT LEAD UP TO THE EVENT?" WHAT WAS THE CAUSE OF DEATH: FAILING KIDNEYS WAS THE CAUSE OF DEATH. STOPPED GOING TO DIALYSIS, CUSTOMER WAS TIRED OF GOING. DEALT WITH 45 YEARS OF DIABETES. DOCTOR'S NAME AND PHONE NUMBER (ATTENDING DOCTOR OR ON FILE IN SAP?): (B)(6). CONTACT INFO OF OTHER PARTIES INVOLVED OR KNOWLEDGEABLE ABOUT CUSTOMER'S PASSING: NA. REQUESTS THAT THE CALLER RETURN THE PUMP. DOCUMENT THE CALLER'S RESPONSE TO THIS REQUEST: YES, HUSBAND WANTED TO SEND THE PUMP BACK. DOES THE CALLER WANT THE PUMP BACK AFTER ANALYSIS IS COMPLETE? DOCUMENT: RESPONSE, NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK SET PARADIGM INFUSION SET FPA UNOMEDICAL DEVICE S.A. DE C.V. MMT-397 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death