BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3803002 · Received May 9, 2014

    Report

    Report Number
    1416980-2014-15015
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    March 21, 2014
    Report Date
    April 16, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, 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 H13L27053 AND H14A18038. THERE WERE NO ISSUES DETECTED DURING THE MANUFACTURING PROCESSES. AS THE SAMPLE WAS NOT RETURNED, A COMPLETE DEVICE EVALUATION CANNOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) EXPERIENCED PERITONITIS MANIFESTED BY ABDOMINAL DISCOMFORT. ON THE SAME DAY, THE PT WAS HOSPITALIZED FOR THE EVENT. THE CAUSE OF PERITONITIS WAS UNKNOWN. ON AN UNKNOWN DATE, THE PT BEGAN TREATMENT WITH CEFEPIME (2 GRAMS, ONE TIME) IP FOR PERITONITIS. AFTER SOME TIME, THE TREATMENT HAS BEEN STOPPED. ON AN UNKNOWN DATE, THE PT RESTARTED THE TREATMENT WITH CEFEPIME (1 GRAM AND FREQUENCY NOT REPORTED) IP FOR PERITONITIS. ON AN UNREPORTED DATE, THE PT WAS RETRAINED IN ASEPTIC TECHNIQUE. THREE DAYS AFTER THE ONSET OF PERITONITIS, THE PT WAS DISCHARGED FROM THE HOSPITAL. ON AN UNKNOWN DATE, THE FOLLOWING MONTH, TREATMENT WITH CEFEPIME WAS STOPPED. AT THE TIME OF THIS REPORT, THE PT WAS RECOVERING FROM THE PERITONITIS EVENT AND PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE. THIS IS REPORT 1 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281729 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R DIANEAL PD4 1.5% AND 2.5% AMBUFLEX| HOMECHOICE| MINICAP| EXTENSION SET| MINICAP TRANSFER SET