BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3812108 · Received May 15, 2014

    Report

    Report Number
    1416980-2014-15542
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    April 22, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED. SAME PT AS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H13L22013 AND H14B10017 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. AS THE SAMPLE WAS NOT RETURNED, A COMPLETE DEVICE ANALYSIS CANNOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) EXPERIENCED PERITONITIS. THE CAUSE OF PERITONITIS WAS UNKNOWN. THE PT WAS HOSPITALIZED FOR THE EVENT. ON AN UNREPORTED DATE, THE PT WAS TREATED WITH VANCOMYCIN (2 GRAMS LOADING DOSE PLUS 1 GRAM EVERY 3 DAYS FOR 2 WEEKS AND ROUTE NOT REPORTED) FOR PERITONITIS. ON AN UNREPORTED DATE, THE PT WAS RECOVERED FROM THE EVENT. THREE DAYS AFTER ADMISSION TO THE HOSPITAL, THE PT WAS DISCHARGED. AT THE TIME OF THIS REPORT, THE PT WAS RECOVERED FROM THE PERITONITIS EVENT AND PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE. THIS IS REPORT 1 OF 2 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290006 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R HOMECHOICE| MINICAP TRANSFER SET| DIANEAL PD4 AMBUFLEX