BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4243429 · Received November 11, 2014

    Report

    Report Number
    1416980-2014-39897
    Event Type
    Death
    Date Received
    November 11, 2014
    Report Date
    October 16, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED AND THE SERIAL NUMBER OF THE DEVICE WAS UNKNOWN; THEREFORE, A DEVICE ANALYSIS, EVENT HISTORY LOG REVIEW, SERVICE HISTORY REVIEW, AND DEVICE HISTORY REVIEW COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: CMPLNT-(B)(4)SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED. SAME PATIENT AS CMPLNT-(B)(4), CMPLNT-(B)(4), CMPLNT-(B)(4) AND CMPLNT-(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A HEART ATTACK AND SUBSEQUENTLY PASSED AWAY DUE TO AN UNKNOWN CAUSE COINCIDENT WITH AUTOMATED PERITONEAL DIALYSIS (APD) THERAPY. TWO WEEKS PRIOR TO DEATH, THE PATIENT WAS HOSPITALIZED FOR ANOTHER INDICATION. ON AN UNKNOWN DATE DURING THE HOSPITALIZATION, THE PATIENT EXPERIENCED A HEART ATTACK. THE TREATMENT FOR THE HEART ATTACK WAS UNKNOWN. SUBSEQUENTLY THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS UNKNOWN. APD THERAPY REMAINED ONGOING UNTIL THE PATIENT¿S DEATH. IT WAS UNKNOWN IF THE PATIENT WAS USING OWN HOMECHOICE OR A HOSPITAL DEVICE. IT WAS UNKNOWN IF THE PATIENT WAS CONNECTED TO A HOMECHOICE AT THE TIME OF DEATH. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. IT WAS NOT REPORTED IF AN END STAGE RENAL DISEASE (ESRD) DEATH NOTIFICATION WAS AVAILABLE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725789 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H DIANEAL 1.5% & 2.5% AMBUFLEX