BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP

    MDR report key: 2991567 · Received March 6, 2013

    Report

    Report Number
    1416980-2013-05388
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 9, 2013
    Report Date
    February 13, 2013
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K972579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    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. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR ASSOCIATED LOT NUMBER 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. THE PROBLEM WAS NOT CONFIRMED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED. NO ASSIGNABLE CAUSE WAS DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH THERAPY FOR PERITONEAL DIALYSIS (PD). THE PATIENT EXPERIENCED A COUGH AND WAS DIAGNOSED WITH BRONCHITIS. THE CAUSE OF THE BRONCHITIS WAS THE PATIENT'S MEDICAL HISTORY OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). THE PATIENT WAS TREATED FOR THE COUGH AND BRONCHITIS WITH PREDNISONE AND UNSPECIFIED ANTIBIOTICS. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED TRAUMA TO THEIR PD CATHETER EXIT SITE, CAUSED BY THEIR COUGH, AND THE PD CATHETER MIGRATED. ON A LATER DATE, THE PATIENT EXPERIENCED PERITONITIS AND WAS ADMITTED TO THE HOSPITAL. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. TREATMENT INFORMATION WAS NOT REPORTED. THE PATIENT'S PD CATHETER WAS PULLED AND PD THERAPIES WERE DISCONTINUED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND HAS RECOVERED FROM THE EVENTS OF COUGH, BRONCHITIS, TRAUMA TO THE PD CATHETER EXIT SITE AND PERITONITIS. THIS IS THE SAME PATIENT AS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95472 FLEXICAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization HOMECHOICE, DIANEAL AMBUFLEX, DIANEAL ULTRABAG| EXTRANEAL