BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4111434 · Received September 23, 2014

    Report

    Report Number
    1416980-2014-32853
    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 PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS EVENT WAS NOT REPORTED. IT WAS UNKNOWN IF THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. THE TREATMENT AND OUTCOME OF THE PERITONITIS WERE NOT REPORTED. A MONTH PRIOR TO THE ONSET OF THE PERITONITIS EVENT, THE PATIENT WAS SWITCHED TO HEMODIALYSIS (HD) THERAPY AND WAS DOING PERITONEAL LAVAGE ONCE A DAY. THE ACTION TAKEN WITH HD THERAPY AND PERITONEAL LAVAGE WAS NOT REPORTED. 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
    590002 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

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