BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1991504 · Received February 15, 2011

    Report

    Report Number
    1423500-2011-01979
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 22, 2011
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    NURSE

    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 510(K) NUMBER WILL NOT BE PROVIDED 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 CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION FROM A NURSE FROM (B)(6) OF PERITONITIS, BREAK IN ASEPTIC TECHNIQUE, FEVER AND VOMITING IN A (B)(6) MALE PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPIES. IN 2005 OR 2006, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 ULTRABAG (DOSE, FREQUENCY AND LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR CAPD (CONTINUOUS AMBULATORY PERITONEAL DIALYSIS). ON (B)(6) 2011, (2 DAYS PRIOR TO THE EVENT) THE PATIENT HAD A BREAK IN ASEPTIC TECHNIQUE DESCRIBED AS PATIENT'S SIBLING ASSISTED IN DOING EXCHANGE FOR THE FIRST TIME. (IT WAS THE PATIENT'S FIRST CASE OF PERITONITIS AFTER 5 YEARS OF THERAPY). ON AN UNREPORTED DATE, THE PATIENT DEVELOPED ABDOMINAL PAIN, A FEVER OF 38 DEGREES CELSIUS, FIBRIN, VOMITING, AND THE PERITONEAL EFFLUENT DESCRIBED AS TURBID. ON (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH PERITONITIS AND WAS HOSPITALIZED. ON AN UNREPORTED DATE, THE PATIENT RECEIVED TREATMENT WITH GENTAMYCIN 8 MG/L OF PERITONEAL DIALYSIS (PD) SOLUTION, LOADING DOSE, FOLLOWED BY 4 MG/L IN PD SOLUTION THEREAFTER. THE PATIENT ALSO RECEIVED CIPROFLOXACIN 500 MG TID (ROUTE NOT REPORTED). IT WAS NOT REPORTED IF TREATMENT HAD CONTINUED. AS OF THE TIME OF THIS REPORT, THE PATIENT REMAINED HOSPITALIZED WITH THE EVENT OF PERITONITIS ONGOING AND UNCHANGED. THE OUTCOME FOR THE BREAK IN ASEPTIC TECHNIQUE, FEVER AND VOMITING WAS NOT REPORTED. IT WAS NOT REPORTED IF PD THERAPY HAD CONTINUED. THE NURSE BELIEVED THE EVENT OF PERITONITIS WAS UNRELATED TO PD THERAPY, AND DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENTS OF BREAK IN ASEPTIC TECHNIQUE, FEVER AND VOMITING.

    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 19 YR Hospitalization| R CATAPRES| FERROUS SULFATE| HEPARIN| CALCIUM CARBONATE| SODIUM CHLORIDE| AMLODIPINE