BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2991225 · Received March 6, 2013

    Report

    Report Number
    1416980-2013-05386
    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
    FKX
    PMA / PMN Number
    K923065
    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 H12I14016 AND H12H13051 AND 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. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. 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. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95983 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

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