BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4270486 · Received November 21, 2014

    Report

    Report Number
    1416980-2014-41941
    Event Type
    Injury
    Date Received
    November 21, 2014
    Report Date
    October 28, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). THE PATIENT EXPERIENCED PERITONITIS ON AN UNKNOWN DATE IN (B)(6) 2013. 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. THIS IS THE SAME PATIENT AS (B)(4). THE INFORMATION PROVIDED WAS FOUND IN THE FOLLOWING ARTICLE: ONUIGBO, MACAULAY A.C. "UNEXPLAINED HYPOTENSION AND EXERTIONAL DYSPNEA IN A NIGHT-CYCLED PERITONEAL DIALYSIS PATIENT¿A RARE FORM OF ICODEXTRIN HYPERSENSITIVITY." ADVANCES IN PERITONEAL DIALYSIS. 30(2014): 87-9.]

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED FOR THE PERITONITIS; HOWEVER, SPECIFIC TREATMENT DETAILS WERE NOT REPORTED. IT WAS NOT REPORTED IF THE PATIENT HAD RECOVERED FROM THE PERITONITIS EVENT. THIS IS REPORT 2 OF 3 INVOLVED IN THIS PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757079 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention DEXTROSE 2.5% AND 4.25%| TRANSFER SET, TITANIUM ADAPTER| ICODEXTRIN