BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3905347 · Received July 1, 2014

    Report

    Report Number
    1416980-2014-21014
    Event Type
    Injury
    Date Received
    July 1, 2014
    Report Date
    June 6, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DATE OF ONSET WAS IN MAY 2014. AS THE SAMPLE WAS NOT RETURNED, A DEVICE EVALUATION CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SAME PATIENT AS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H14D13017, H14C18075, AND H14B06023. THERE WERE NO ISSUES DETECTED DURING THE MANUFACTURING PROCESSES. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. IN THE MONTH PRIOR TO THE RECEIPT OF THIS REPORT, THE PATIENT WAS HOSPITALIZED FOR ANOTHER INDICATION. ON AN UNREPORTED DATE DURING HOSPITALIZATION, THE PATIENT EXPERIENCED PERITONITIS. THE PERITONITIS WAS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY EFFLUENT. THE NURSE REPORTED THAT THE CAUSE OF PERITONITIS WAS UNKNOWN, BUT ALSO REPORTED THAT THE PATIENT TOLD THE NURSE THAT HE HAD DROPPED HIS TRANSFER SET. THE PATIENT WAS RETRAINED ON PROPER ASEPTIC TECHNIQUE. IN THE SAME MONTH AS THE HOSPITALIZATION, THE PATIENT WAS TREATED WITH 1 GRAM CEFTAZIDIME INTRAPERITONEALLY (IP) FOR PERITONITIS. TEN DAYS AFTER ADMISSION TO THE HOSPITAL, THE PATIENT WAS DISCHARGED. SEVENTEEN DAYS AFTER DISCHARGE, TREATMENT WITH CEFTAZIDIME WAS DISCONTINUED. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM PERITONITIS AND PD THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383136 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

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