BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3903152 · Received June 30, 2014

    Report

    Report Number
    1416980-2014-20929
    Event Type
    Death
    Date Received
    June 30, 2014
    Report Date
    April 1, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PT AGE: THE PATIENT WAS BORN ON AN UNSPECIFIED DATE IN 1938. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION COULD NOT BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT WHO PERFORMED THERAPY WITH A HOMECHOICE DEVICE (HC) PASSED AWAY. THE CAUSE OF DEATH WAS REPORTED AS A HEART ATTACK. TREATMENT WAS NOT REPORTED. IT WAS NOT REPORTED IF PD THERAPY WAS ONGOING UNTIL THE TIME OF DEATH OR IF THE PATIENT WAS CONNECTED TO THE HC DEVICE AT THE TIME OF DEATH. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380510 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death ATORVASTATIN, BISOPROLOL, EPREX,| TRAMADOL, INSULIN NOVO RAPID,| MOVICOL, PANTOPRAZOLE, SENNA,| LEVEMIR INSULIN, VITAMIN B COMPOUND STRONG,| ALFACALCIDOL, ALLOPURINOL, AMLODIPINE,| DIANEAL PD4 1.36% AND 2.27%| FOLIC ACID, FUROSEMIDE, GENTAMYCIN,| WARFARIN,