BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPD DISCONNECT Y SET

    MDR report key: 3023415 · Received March 27, 2013

    Report

    Report Number
    1416980-2013-07425
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    February 23, 2013
    Report Date
    March 4, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K961825
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR THE POTENTIALLY ASSOCIATED LOT NUMBER H12L15075. NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THIS IS A REPORT OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL THERAPY AUTOMATED PERITONEAL DIALYSIS (APD). DIANEAL THERAPY WAS ONGOING. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERITONITIS MANIFESTED AS ABDOMINAL PAIN AND WAS HOSPITALIZED FOR THE EVENT. THE CAUSE OF PERITONITIS WAS UNKNOWN. ON AN UNKNOWN DATE, THE PATIENT WAS TREATED WITH VANCOMYCIN (DOSE AND FREQUENCY UNKNOWN) IP FOR PERITONITIS. THE PATIENT WAS RE-TRAINED ON A PROPER ASEPTIC TECHNIQUE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT. THIS IS REPORT 4 OF 5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126280 CAPD DISCONNECT Y SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R HOMECHOICE AND DIANEAL PD4 AMBUFLEX