BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4111340 · Received September 23, 2014

    Report

    Report Number
    1416980-2014-32829
    Event Type
    Injury
    Date Received
    September 23, 2014
    Report Date
    August 27, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TITLE OF THE LITERATURE ARTICLE: A CASE OF ENCAPSULATING PERITONEAL SCLEROSIS DEVELOPED IN RELATIVELY SHORT DURATION OF PERITONEAL DIALYSIS. KINOSHITA K. AUG2014. THE DATE OF ONSET OF THE PERITONITIS EVENT WAS ON AN UNREPORTED DATE IN (B)(6) 2013. FACILITY NAME - (B)(6). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER MINICAP. AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. THIS IS SAME PATIENT AS IN (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SCLEROSING ENCAPSULATING PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE SCLEROSING ENCAPSULATING PERITONITIS WAS MANIFESTED BY BLOODY EFFLUENT AND ABDOMINAL PAIN. THE CAUSE OF THE SCLEROSING ENCAPSULATING PERITONITIS EVENT WAS NOT REPORTED. ON AN UNREPORTED DATE, THE PATIENT WAS HOSPITALIZED FOR THE REPORTED EVENT. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH PREDNISOLONE (20MG/DAY, ROUTE NOT REPORTED) FOR THE REPORTED EVENT. THE OUTCOME OF THE REPORTED EVENT WAS NOT REPORTED. THE FOLLOWING MONTH AFTER THE ONSET OF THE EVENT, THE PD THERAPY WAS DISCONTINUED AND THE PATIENT WAS SWITCHED TO HEMODIALYSIS THERAPY. AFTER THAT, THE PATIENT PERFORMED PERITONEAL LAVAGE ONCE A DAY. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THIS TIME. THIS IS REPORT 2 OF 3 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590331 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R MINICAP TRANSFER SET, TITANIUM ADAPTER| DIANEAL N 1.5 % PD4, EXTRANEAL