BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1769243 · Received July 23, 2010

    Report

    Report Number
    1423500-2010-01626
    Event Type
    Injury
    Date Received
    July 23, 2010
    Date of Event
    February 26, 2010
    Report Date
    May 3, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTED INFORMATION: INFORMATION RECEIVED FROM BAXTER'S GLOBAL PHARMACOVIGILANCE DATED (B)(6) 2010 INDICATES A NURSE REPORTED THE PATIENT DEVELOPED PERITONITIS ON 2 SEPARATE OCCASIONS. THE FIRST EVENT THE PATIENT WAS ADMITTED TO THE HOSPITAL FROM (B)(6) 2010 (SEE MDR #1423500-2010-001625) AND REPORTEDLY RECOVERED FROM THIS EVENT OF PERITONITIS. THE SECOND EVENT THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2010 UNTIL (B)(6) 2010 AND REPORTED UNDER A PREVIOUS COMPLAINT (SEE MDR#1423500-2010-00647).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED THEREFORE, NO EVALUATION WAS PERFORMED.

    Description of Event or Problem · 1

    A NURSE REPORTED TWO SEPARATE INCIDENTS OF PERITONITIS ON THE SAME PATIENT. THIS REPORT IS FOR THE SECOND INCIDENT OF PERITONITIS IN WHICH THE PATIENT WAS ADMITTED TO THE HOSPITAL FROM (B)(6)2010 TO (B)(6)2010. THE CAUSE FOR THIS INCIDENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R