BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3980324 · Received August 5, 2014

    Report

    Report Number
    1416980-2014-25317
    Event Type
    Injury
    Date Received
    August 5, 2014
    Report Date
    July 11, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON AN UNREPORTED DATE IN (B)(6) 2014, THE PATIENT EXPERIENCED PERITONITIS. 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 H14D17109 AND H14C12094. THERE WERE NO ISSUES DETECTED DURING THE MANUFACTURING PROCESSES ASSOCIATED WITH THE REPORTED ISSUE. 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. THE CAUSE OF THE EVENT WAS NOT REPORTED. THE FOLLOWING MONTH, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. TREATMENT FOR THE PERITONITIS EVENT WAS NOT REPORTED. FOUR DAYS AFTER ADMISSION TO THE HOSPITAL, THE PATIENT WAS DISCHARGED. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM PERITONITIS AND PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS NOT AVAILABLE. THIS IS REPORT 1 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456495 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization MINICAP, EXTENSION SET| HOMECHOICE| DIANEAL PD4 1.5% AND 2.5% AMBUFLEX