BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4200438 · Received October 24, 2014

    Report

    Report Number
    1416980-2014-37298
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    August 22, 2014
    Report Date
    September 29, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER MINICAP. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS IS THE SAME PATIENT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED STERILE PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS THERAPY, MANIFESTED BY FEVER, ABDOMINAL PAIN, AND CLOUDY FLUID. ON THE SAME DAY AS THE EVENT, THE PATIENT WAS HOSPITALIZED. THE PATIENT BEGAN TREATMENT WITH INTRAVENOUS VANCOMYCIN (1G TIMES SIX DOSES) FOR PERITONITIS. FIVE DAYS AFTER THE EVENT, THE VANCOMYCIN WAS DISCONTINUED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ACTION TAKEN WITH THERAPY WAS NOT REPORTED. WHILE STILL RECOVERING THIRTEEN DAYS AFTER THE EVENT, THE PATIENT AGAIN EXPERIENCED STERILE PERITONITIS MANIFESTED BY FEVER, ABDOMINAL PAIN, AND CLOUDY FLUID. ON THE SAME DAY, THE PATIENT BEGAN TREATMENT WITH ORAL CIPRO (500 MG TWICE DAILY; DURATION NOT REPORTED) FOR PERITONITIS. THE PATIENT ALSO STARTED HEMODIALYSIS AT THIS TIME. THE PATIENT WAS NOT READMITTED TO THE HOSPITAL FOR PERITONITIS. NINETEEN DAYS AFTER THE EVENT, THE PATIENT HAD THEIR PERITONEAL DIALYSIS CATHETER REMOVED. TWENTY-SIX DAYS AFTER THE EVENT, THE PATIENT RECOVERED FROM PERITONITIS. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678945 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R DIANEAL 1.5% PD 2 ULTRABAG, TRANSFER SET