BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3231796 · Received July 17, 2013

    Report

    Report Number
    1416980-2013-18768
    Event Type
    Injury
    Date Received
    July 17, 2013
    Report Date
    June 23, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER H13C24033 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. A SAMPLE WAS NOT AVAILABLE FOR ANALYSIS. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A SUPPLEMENTAL MDR WILL BE SUBMITTED. THIS IS THE SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT (HP) HAD EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY MANIFESTED BY ABDOMINAL PAIN DURING FILL. THE CAUSE OF PERITONITIS WAS UNKNOWN. TREATMENT WAS NOT REPORTED. THE OUTCOME OF THE EVENT WAS NOT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT AVAILABLE AT THIS TIME. THIS REPORT IS 1 OF 3 FOR THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331258 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MINICAP TRANSFER SET, MINICAP| HOMECHOICE, DIANEAL PD4 AMBUFLEX