BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION SET

    MDR report key: 2991259 · Received March 6, 2013

    Report

    Report Number
    1416980-2013-05391
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 9, 2013
    Report Date
    February 13, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H12K28047 AND H12K09146 AND NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 1

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

    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
    96296 EXTENSION SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

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