BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP

    MDR report key: 3081867 · Received April 29, 2013

    Report

    Report Number
    1416980-2013-10618
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    March 10, 2013
    Report Date
    April 4, 2013
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K972579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOT NUMBER(S) 12J16H25 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.

    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 RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD). DIANEAL THERAPY WAS WITHDRAWN AND THE PATIENT WAS TO SWITCHED TO HEMODIALYSIS (HD). THE PATIENT EXPERIENCED ABDOMINAL PAIN WHICH WAS BELIEVED TO BE RELATED TO A COUGH (ONSET DATE UNKNOWN). THE PATIENT WAS HOSPITALIZED FOR THE COUGH AND RESPIRATORY DISTRESS. ON THE SAME DAY, THE PATIENT WAS DIAGNOSED WITH PERITONITIS MANIFESTED BY THE ABDOMINAL PAIN. THE CAUSE OF PERITONITIS WAS UNKNOWN. TREATMENT WAS NOT REPORTED. ON AN UNKNOWN DATE, DURING THE HOSPITALIZATION, THE PATIENT WAS DIAGNOSED WITH SEPSIS AS EVIDENCED BY BLOOD CULTURES POSITIVE FOR (B)(6). THE SOURCE OF THE SEPSIS WAS UNKNOWN. ON AN UNKNOWN DATE, THE PD CATHETER WAS REMOVED AND A CENTRAL LINE WAS PLACED FOR HEMODIALYSIS AS A RESULT OF SEPSIS. THE PATIENT REMAINED HOSPITALIZED. THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT. THIS IS REPORT 4 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183515 FLEXICAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization DIANEAL PD4 AMBUFLEX