BEUDAMED
    FDA Adverse Event Death Summary report: N

    REN - HARDWARE

    MDR report key: 1980416 · Received February 7, 2011

    Report

    Report Number
    1423500-2011-01572
    Event Type
    Death
    Date Received
    February 7, 2011
    Date of Event
    January 22, 2011
    Report Date
    January 22, 2011
    Product Code
    FKX
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED BY BAXTER (B)(4): FOLLOW UP INFORMATION WAS RECEIVED FROM THE PHYSICIAN. ON (B)(6) 2011, THE PATIENT DIED. THE CAUSE OF DEATH WAS SEPSIS. THE PD THERAPIES WERE ONGOING. PER THE PHYSICIAN, THIS EVENT WAS NOT RELATED TO DIANEAL-N AND EXTRANEAL THERAPIES. UPON REVIEW OF THE ADDITIONAL INFORMATION RECEIVED, BAXTER HAS DETERMINED IT IS UNLIKELY THAT THE HOMECHOICE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S SEPSIS. THERE HAS BEEN NO ALLEGATION OF A DEVICE MALFUNCTION.

    Additional Manufacturer Narrative · 1

    (B)(4) - THE DEVICE AVAILABILITY IS UNKNOWN AT THIS TIME. THE DEVICE SERIAL NUMBER AND MANUFACTURER INVOLVED IN THE INCIDENT IS UNKNOWN AT THIS TIME. A 510K NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510K NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE RECEIPT OF FURTHER INFORMATION OR IF THE DEVICE IS RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CONSUMER REPORT BY A PATIENT'S FAMILY FROM (B)(6) OF DEATH IN A MALE PATIENT COINCIDENT WITH DIANEAL UNKNOWN THERAPY. ON AN UNKNOWN DATE, THE PATIENT BEGAN DIANEAL UNKNOWN THERAPY. ON (B)(6) 2011, THE PATIENT'S FAMILY CONTACTED BAXTER (B)(4) TO REPORT THAT THE PATIENT HAD DIED. THERE WAS NO FURTHER INFORMATION. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. ON AN UNKNOWN DATE, THE PATIENT BEGAN DIANEAL-N PD4 1.5 , DIANEAL-N PD4 2.5 AND EXTRANEAL THERAPIES (DOSES WERE 1.5L, FREQUENCY WAS NOT REPORTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REN - HARDWARE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX

    Patients

    Seq Age Sex Outcome Treatment
    1 Death EXTRANEAL| DIANEAL-N PD4| DIANEAL-N PD4 2.5%