BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2225258 · Received August 29, 2011

    Report

    Report Number
    1423500-2011-11312
    Event Type
    Death
    Date Received
    August 29, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 5, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS BEING RETURNED TO BAXTER PER THE FAMILY'S REQUEST. SHOULD AN EVALUATION BE PERFORMED OR ADDITIONAL INFORMATION RECEIVED A FOLLOW-UP WILL BE SUBMITTED. BAXTER IS UNSURE IF THIS IS A HOMECHOICE OR HOMECHOICE PRO DEVICE INVOLVED IN THIS INCIDENT; HOWEVER, THE 510K NUMBER IS BEING PROVIDED BECAUSE IT IS THE SAME FOR BOTH DEVICES.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ASSIGNABLE CAUSE OF THE PATIENT DEATH IS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION: THIS WAS A DISPOSABLE UNKNOWN PRODUCT THEREFORE NO 510K NUMBER CAN BE PROVIDED. ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS PROVIDED BY A MEDICAL PROFESSIONAL. THIS CASE WAS MEDICALLY CONFIRMED. MEDICAL HISTORY ALSO INCLUDED DIABETES MELLITUS AGGRAVATED, GANGRENE, LEG AMPUTATION AND GENERALLY UNWELL. THE REPORTER STATED THAT THE CAUSE OF DEATH WAS UNRELATED TO PD THERAPIES. THE REPORTER DECLINED TO PROVIDE FURTHER INFORMATION.

    Description of Event or Problem · 1

    THE PATIENT'S FAMILY CALLED AS THE PATIENT PASSED AWAY AND REQUESTED SUPPLIES BE RETRIEVED. ON AN UNREPORTED DATE, THE PATIENT BEGAN DIANEAL-N PD-2 2.5 AND EXTRANEAL THERAPIES FOR RENAL FAILURE CHRONIC. ON (B)(6) 2011, THE FAMILY MEMBER REPORTED THAT THE PATIENT PASSED AWAY (DATE NOT REPORTED). THE CAUSE OF DEATH, TREATMENT OR STATUS OF HOSPITALIZATION PRIOR TO HER DEMISE, IF AN AUTOPSY WAS PERFORMED, AND IF PD THERAPIES WERE ONGOING UNTIL DEATH WERE UNREPORTED. THE PHYSICIAN STATED THAT THE EVENT OF DEATH WAS UNRELATED TO DIANEAL-N PD-2 2.5 AND EXTRANEAL THERAPIES. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death DIANEAL-N PD-2 2.5| EXTRANEAL THERAPY| HOMECHOICE