BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3942492 · Received July 17, 2014

    Report

    Report Number
    1416980-2014-23097
    Event Type
    Injury
    Date Received
    July 17, 2014
    Report Date
    June 24, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON AN UNREPORTED DATE IN (B)(6) 2014, THE PT EXPERIENCED PERITONITIS. ON AN UNKNOWN DATE BETWEEN (B)(6) 2014, THE PT WAS DISCHARGED FROM THE HOSPITAL. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBER H14C30070. THERE WERE NO ISSUES DETECTED DURING THE MANUFACTURING PROCESSES. AS THE SAMPLE WAS NOT RETURNED, A 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. ONE DAY PRIOR TO THE RECEIPT OF THIS REPORT, THE PT WAS HOSPITALIZED FOR THE EVENT. THE CAUSE OF PERITONITIS WAS UNKNOWN. ON AN UNKNOWN DATE, THE PT WAS TREATED WITH RIFAMPIN (DOSE AND FREQUENCY NOT REPORTED) ORALLY FOR PERITONITIS. AT THE TIME OF THIS REPORT, TREATMENT WITH RIFAMPIN WAS ONGOING. ON AN UNREPORTED DATE, THE PT WAS RETRAINED IN ASEPTIC PROCEDURES FOR PERFORMING PD THERAPY. AT THE TIME OF THIS REPORT, THE PERITONITIS WAS RESOLVING, THE PT WAS RECOVERING, AND DIANEAL THERAPIES WERE ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 1 OF 2 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418272 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL PD4, 2.5% AMBUFLEX| HOMECHOICE| DIANEAL PD4, 1.5% AMBUFLEX| DIANEAL PD, 4.25% AMBUFLEX| MINICAP TRANSFER SET