BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3150568 · Received June 6, 2013

    Report

    Report Number
    1416980-2013-14499
    Event Type
    Death
    Date Received
    June 6, 2013
    Report Date
    May 14, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENTS WERE REPORTED TO HAVE OCCURRED IN (B)(6) 2013. UPON COMPLETION OF THE INVESTIGATION, OR IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT FROM A NURSE OF A HOME PATIENT (HP) THAT PASSED AWAY. THE CAUSE OF THIS PATIENT'S DEATH IS UNKNOWN. PRIOR TO THE DEATH, THE PATIENT EXPERIENCED FALLS THAT WERE UNRELATED TO PERITONEAL DIALYSIS (PD) THERAPY, DISPOSABLES, SOLUTIONS, OR DEVICE. AS A RESULT OF THE FALLS, THE PATIENT EXPERIENCED FEELING PAIN IN LEGS, SHOULDERS, LOWER BACK, RIGHT SIDED PAIN, AND VOMITING. THE PATIENT WAS EXPERIENCING VOMITING AND WENT TO THE EMERGENCY ROOM. THE NURSE CLARIFIED THE PATIENT DID NOT EXPERIENCE ABDOMINAL PAIN. THE CAUSE OF VOMITING WAS UNKNOWN. DURING HOSPITALIZATION, THE PATIENT WAS FOUND TO HAVE BLOOD IN THE LUNGS. THE NURSE WAS UNABLE TO PROVIDE CAUSALITY FOR THE REPORTED EVENT OF BLOOD IN THE LUNGS. THE NURSE DOESN'T KNOW IF PERITONITIS WAS OFFICIALLY DIAGNOSED OR WHAT TREATMENT WAS RECEIVED DURING THE HOSPITALIZATION. PD THERAPY WAS DISCONTINUED ON AN UNKNOWN DATE AND THE PATIENT DIED THE NEXT MONTH. PER THE NURSE, THE PATIENT WAS NOT CONNECTED TO THE HOME CHOICE DEVICE AT THE TIME OF DEATH NOR DID HE EXPERIENCE AN OVERFILL EVENT THAT MAY HAVE CONTRIBUTED. THE NURSE STATES THE PATIENT'S SPOUSE REPORTED THE DEATH AS CARDIAC FAILURE. THE NURSE HAS VERY LIMITED INFORMATION DUE TO NOT HAVING ACCESS TO THE PATIENT'S HOSPITAL RECORDS. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED. THE NURSE WAS UNABLE TO PROVIDE CAUSALITY FOR THE REPORT OF VOMITING, POSITIVE EFFLUENT CULTURE (STREPTOCOCCUS IN PERITONEUM), BLOOD IN LUNGS, AND DEATH. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249978 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H DIANEAL 1.5% LOW CAL AMBUFLEX,| EXTRANEAL