BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2023703 · Received March 18, 2011

    Report

    Report Number
    1423500-2011-03372
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    May 1, 2009
    Report Date
    February 23, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    PHYSICIAN

    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. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS IS A REPORT BY A PHYSICIAN FROM (B)(6) OF BREAK IN ASEPTIC TECHNIQUE PYREXIA AND BACTERIAL PERITONITIS WITH (B)(6) IN A PATIENT COINCIDENT WITH DIANEAL, UNKNOWN THERAPY (LOT NUMBER NOT REPORTED). ON (B)(6) 2009, THE PATIENT BEGAN TREATMENT WITH DIANEAL UNKNOWN (DOSE, FREQUENCY AND LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON AN UNREPORTED DATE, A BREAK IN ASEPTIC TECHNIQUE OCCURRED, DESCRIBED AS PATIENT COOLED THE HEATED SOLUTION (ON (B)(6) 2009) AND USED IT AFTER THAT. ON (B)(6) 2009, THE PATIENT EXPERIENCED ABDOMINAL PAIN AND PYREXIA. THE PATIENT WAS DIAGNOSED WITH A BACTERIAL PERITONITIS, WHICH WAS CONSIDERED MILD. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. FROM (B)(6) 2009 TO (B)(6) 2009, THE PATIENT RECEIVED ANTIBIOTIC TREATMENT WITH CEFUROXIMUM 750 MG, IP, TWICE A DAY AND GENTAMYCINUM 40 MG, IP, ONCE DAILY. FROM (B)(6) 2009 TO (B)(6) 2009 THE PATIENT RECEIVED AMOXICILINUM/ACIDUM CLAVULONICUM 1.2 GRAMS, IP, TWICE DAILY. ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THE PERITONITIS AND PYREXIA. THE OUTCOME FOR THE EVENT OF BREAK IN ASEPTIC TECHNIQUE WAS NOT REPORTED. ACTION TAKEN WITH DIANEAL WAS NOT REPORTED. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PHYSICIAN STATED THE EVENT OF BACTERIAL PERITONITIS WITH (B)(6) (WITH PYREXIA) WAS UNRELATED TO DIANEAL. THE PHYSICIAN DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENT OF BREAK IN ASEPTIC TECHNIQUE. THE ROOT CAUSE OF THE BACTERIAL PERITONITIS WAS A BREAK IN ASEPTIC TECHNIQUE, DESCRIBED AS PATIENT COOLED THE HEATED SOLUTION (ON (B)(6) 2009) AND USED IT AFTER THAT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention DIANEAL