BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3802562 · Received May 9, 2014

    Report

    Report Number
    1416980-2014-14933
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 14, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PDRN CONFIRMED THAT THE PATIENT DID NOT HAVE PERITONITIS, THEREFORE THE HOMECHOICE AUTOMATED PD SET WITH CASSETTE IS NO LONGER CONSIDERED A SUSPECT PRODUCT IN THIS EVENT. A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOT NUMBERS H13L21031 AND H14B03087 WAS PERFORMED 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. THE CAUSE WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION COULD NOT BE CONDUCTED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. SEVEN DAYS PRIOR TO RECEIPT OF THIS REPORT, THE PATIENT PRESENTED TO THE EMERGENCY ROOM FOR MULTIPLE INDICATIONS AND WAS HOSPITALIZED. THE SAME DAY WHILE HOSPITALIZED, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PERITONITIS WAS MANIFESTED BY CLOUDY EFFLUENT. THE SAME DAY THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS GIVEN INTRAPERITONEAL (IP) ¿NIGHTLY¿ (DOSE NOT REPORTED). THE ANTIBIOTICS WERE SCHEDULED TO CONTINUE FOR 17 DAYS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS DISCHARGED 3 DAYS AFTER ADMISSION. AT THE TIME OF THIS REPORT THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 2 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281673 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R DIANEAL PD4 LOW CALCIUM 1.5% AND 2.5% SOLUTIONS| HOMECHOICE, MINICAP