BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1972274 · Received January 28, 2011

    Report

    Report Number
    1423500-2011-01152
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 5, 2011
    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. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THIS IS A SOLICITED REPORT BY A PHYSICIAN FROM (B)(6) OF BACTERIAL PERITONITIS WITH (B)(6) IN A PATIENT (AGE NOT REPORTED), COINCIDENT WITH DIANEAL UNKNOWN BAG THERAPY (LOT NUMBER NOT REPORTED). THIS REPORT WAS RECEIVED BY BAXTER (B)(4) FROM (B)(6). ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL UNKNOWN BAG THERAPY (DOSE, FREQUENCY AND LOT NUMBER WAS NOT REPORTED), INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS AND ON AN UNREPORTED DATE IN (B)(6) 2010, WAS HOSPITALIZED. ON AN UNREPORTED DATE IN (B)(6) 2010, THE PATIENT BEGAN REMEDIAL THERAPY WITH CIPROFLOXACIN, IP (DOSE AND FREQUENCY WERE NOT REPORTED) AND VANCOMYCIN, IP (DOSE AND FREQUENCY WERE NOT REPORTED). ON AN UNREPORTED DATE IN (B)(6) 2010, DIANEAL WAS WITHDRAWN AND REPLACED WITH AN UNSPECIFIED FRESENIUS PD SOLUTION. DIANEAL THERAPY WAS NOT REINTRODUCED. AT THE TIME OF THIS REPORT, IT WAS NOT REPORTED WHETHER THE ANTIBIOTIC THERAPY WAS ONGOING. ALTHOUGH IT WAS REPORTED THE BACTERIAL PERITONITIS IMPROVED FOLLOWING REMEDIAL THERAPY, THE OUTCOME WAS NOT SPECIFICALLY REPORTED. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PHYSICIAN DID NOT PROVIDE A CAUSALITY STATEMENT FOR THE EVENT OF BACTERIAL PERITONITIS.

    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 Hospitalization| R DIANEAL