BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4220198 · Received November 3, 2014

    Report

    Report Number
    1416980-2014-38446
    Event Type
    Death
    Date Received
    November 3, 2014
    Report Date
    October 8, 2014
    Manufacturer
    BAXTER HEATHCARE CORPORATION
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A PATIENT DIED COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE CAUSE OF DEATH WAS UNKNOWN. IT IS UNKNOWN IF THE PATIENT HAD RECOVERED FROM THE PERITONITIS PRIOR TO DEATH. THE PATIENT PASSED AWAY WHILE HOSPITALIZED FOR AN UNRELATED EVENT. IT WAS UNKNOWN IF AN AUTOPSY WAS PERFORMED OR IF A DEATH CERTIFICATE IS AVAILABLE. IT WAS REPORTED THAT THERAPY WAS ONGOING PRIOR TO DEATH; HOWEVER, IT WAS UNKNOWN IF THE PATIENT WAS PERFORMING THERAPY AT THE TIME OF DEATH. NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT INVOLVES A PATIENT WHO EXPERIENCED AN INFECTION MANIFESTED BY ABDOMINAL PAIN IN THE CONTEXT OF PERITONEAL DIALYSIS. WHILE THERE WAS NO PERITONITIS REPORTED, IT IS CURRENTLY UNABLE TO BE RULED OUT AS A CAUSE FOR THE REPORTED SYMPTOMS. THE REPORTED PRODUCT IS AN UNKNOWN BAXTER MINICAP. AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE EVALUATION CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED AN INFECTION MANIFESTED BY ABDOMINAL PAIN. THE NATURE OF THE INFECTION WAS NOT REPORTED. THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE PATIENT WAS ADMINISTERED UNKNOWN ANTIBIOTICS FOR THE UNSPECIFIED INFECTION. THE PATIENT¿S PD CATHETER WAS DISCONTINUED AND SHE WAS PLACED ON BACK UP HEMODIALYSIS. AT THE TIME OF THIS REPORT, THE PATIENT REMAINED HOSPITALIZED. THE OUTCOME OF THE EVENT WAS UNKNOWN. ADDITIONAL INFORMATION WAS NOT AVAILABLE. THIS IS REPORT 2 OF 3 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701207 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEATHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R HOMECHOICE, TRANSFER SET, CASSETTE| 1.5% DIANEAL PD4,