BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4182500 · Received October 17, 2014

    Report

    Report Number
    1416980-2014-36365
    Event Type
    Death
    Date Received
    October 17, 2014
    Report Date
    September 23, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT EXPERIENCED RECURRENT PERITONITIS AND SUBSEQUENTLY PASSED AWAY DUE TO CARDIAC ARREST. ON AN UNREPORTED DATE, IN THE MONTH PRIOR TO DEATH, THE PATIENT EXPERIENCED ABDOMINAL PAIN AND A HIGH WHITE BLOOD CELL COUNT. DUE TO THE HIGH WHITE BLOOD CELL COUNT, THE PATIENT WAS DIAGNOSED WITH RECURRENT PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON AN UNREPORTED DATE (TOWARD THE END OF THE MONTH UNTIL THE FIRST OF THE FOLLOWING MONTH), THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. THE TREATMENT GIVEN FOR THE RECURRENT PERITONITIS WAS UNKNOWN. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON AN UNREPORTED DATE ¿AROUND THE FIRST OF THE MONTH¿. ONE DAY PRIOR TO DEATH, THE PATIENT HAD THEIR LAST PD THERAPY. ON THE DATE OF DEATH, THE PATIENT RETURNED FROM A DOCTOR¿S OFFICE APPOINTMENT AND SUBSEQUENTLY PASSED AWAY AT HOME. THE CAUSE OF DEATH WAS REPORTED TO BE DUE TO CARDIAC ARREST. THE CAUSE OF DEATH WAS ALSO REPORTED (FROM ANOTHER SOURCE) AS DUE TO NATURAL CAUSES, HOWEVER, THIS WAS NOT CONFIRMED. IT WAS REPORTED THAT THE PATIENT DID NOT RECOVER FROM PERITONITIS PRIOR TO DEATH. THERE WAS NO AUTOPSY PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER MINICAP. ON AN UNREPORTED DATE IN (B)(6) 2014, THE PATIENT EXPERIENCED PERITONITIS. (B)(4). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER OF THE DEVICE WAS UNKNOWN; THEREFORE, A SAMPLE ANALYSIS AND/OR A BATCH REVIEW COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS MANIFESTED BY ABDOMINAL PAIN COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS EVENT. ON UNREPORTED DATE(S), THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTIC(S) INTRAPERITONEALLY (MEDICATION, DOSAGE, FREQUENCY, AND DURATION NOT REPORTED) FOR THE PERITONITIS. DIANEAL THERAPIES WERE ONGOING. THE PATIENT WAS RECOVERED FROM THE PERITONITIS. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 2 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661064 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R HOMECHOICE| DIANEAL 1.5% AND 2.5% PD4 AMBUFLEX,| TRANSFER SET, CASSETTE, TITANIUM ADAPTER