BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1979652 · Received February 6, 2011

    Report

    Report Number
    1423500-2011-01528
    Event Type
    Injury
    Date Received
    February 6, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 13, 2011
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A CONSUMER FROM THE PHILIPPINE OF PROLONG CONNECTION OF Y SET TUBE, BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS IN A FEMALE PATIENT COINCIDENT WITH DIANEAL PD2 UNKNOWN BAG THERAPY. ON (B)(6) 2010, THE PATIENT STARTED TREATMENT WITH DIANEAL PD2 UNKNOWN BAG, (ROUTE, FREQUENCY AND DOSE UNKNOWN), INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON AN UNKNOWN DATE IN 2011, A BREAK IN ASEPTIC TECHNIQUE AND PROLONG CONNECTION OF Y SET TUBE OCCURRED. ON (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH PERITONITIS WHICH WAS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY EFFLUENT. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2011 FOR THE PERITONITIS. IT WAS UNKNOWN IF THE DIANEAL THERAPY WAS ONGOING OR IF THE PERITONITIS WAS RESOLVING. IT WAS NOT REPORTED WHETHER THE PATIENT WAS RETRAINED; THEREFORE, THE OUTCOME FOR THE EVENT OF BREAK IN ASEPTIC AND PROLONG CONNECTION OF Y SET TUBE WERE UNKNOWN. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE REPORTER BELIEVED THAT THE PERITONITIS WAS NOT RELATED TO THE DIANEAL THERAPY, BUT WAS DUE TO THE BREAK IN ASEPTIC TECHNIQUE AND PROLONG CONNECTION OF Y SET TUBE. A CAUSALITY STATEMENT WAS NOT REPORTED FOR THE BREAK IN ASEPTIC TECHNIQUE OR THE PROLONG CONNECTION OF Y SET TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization DIANEAL PD2