BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4103536 · Received September 19, 2014

    Report

    Report Number
    1416980-2014-32497
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 27, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED. THIS REPORT IS FOR AN UNKNOWN MINICAP, (B)(4) ADDRESSES THE TRANSFER SET REPORT, (B)(4) ADDRESSES THE AUTOMATED PD SET WITH CASSETTE REPORT AND (B)(4) ADDRESSES THE TITANIUM ADAPTER REPORT FOR THIS PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR THE REPORTED EVENT. THE TREATMENT FOR PERITONITIS WAS UNSPECIFIED ANTIBIOTICS (DOSAGE, ROUTE, AND FREQUENCY NOT REPORTED). THE CAUSE WAS REPORTED TO BE DUE TO THE PATIENT SWIMMING IN UNCLEAN WATER. WHILE IN THE HOSPITAL, THE PD CATHETER WAS REMOVED AND THE PATIENT WAS STARTED ON HEMODIALYSIS THERAPY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL SIX DAYS AFTER ADMISSION, BUT THEY HAD NOT YET RECOVERED FROM THE PERITONITIS. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THIS TIME. THIS IS REPORT 3 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584262 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization| R DIANEAL PD4 2.5% AMBUFLEX, HOMECHOICE| TRANSFER SET, TITANIUM ADAPTER| AUTOMATED PD SET WITH CASSETTE