BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1945970 · Received January 4, 2011

    Report

    Report Number
    1423500-2011-00018
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    August 1, 2010
    Report Date
    December 13, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 510(K) NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, A BATCH REVIEW WILL NOT 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 NURSE WITH SUPPLEMENTAL INFORMATION BY A PHYSICIAN FROM (B)(6) OF REDUCED GENERAL CONDITION, UNSPECIFIED ALLERGY AND BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD)THERAPY. ON (B)(6) 2010, THE NURSE REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS ON (B)(6) 2010, MANIFESTED BY CLOUDY DIALYSATE, FEVER AND ABDOMINAL PAIN. ON THIS SAME DATE, THE PATIENT BEGAN TREATMENT WITH VANCOMYCIN (DOSE, FREQUENCY AND ROUTE NOT REPORTED) FOR PERITONITIS. ON (B)(6) 2010, THE EVENT AND SYMPTOMS OF PERITONITIS RESOLVED. ON (B)(6) 2010, THE PATIENT COMPLETED TAKING VANCOMYCIN. ON (B)(6) 2010, THE PATIENT'S FEVER REAPPEARED AND EXTRANEAL VIAFLEX, NUTRINEAL PD4 AND PHYSIONEAL WERE DISCONTINUED AND THE PATIENT WAS SWITCHED TO HEMODIALYSIS. AN OUTCOME FOR THE EVENT OF FEVER WAS NOT REPORTED. THE NURSE DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENTS OF FEVER AND PERITONITIS. ON (B)(6) 2010, EXTRANEAL VIAFLEX AND PHYSIONEAL, UNSPECIFIED PRODUCT WERE RE-INTRODUCED. ON (B)(6) 2010, THE PATIENT COMPLETED TAKING VANCOMYCIN. THE PATIENT DEVELOPED AN UNSPECIFIED ALLERGY (DATE NOT REPORTED) AND WAS GIVEN FENISTIL (1 AMPOULE, IV, FREQUENCY NOT REPORTED) AND PREDNISOLONE (100MG, IV, FREQUENCY NOT REPORTED) ON (B)(6) 2010. THE PATIENT RECOVERED FROM THE BACTERIAL PERITONITIS AND REDUCED GENERAL CONDITION (DATE NOT REPORTED). THE SYMPTOMS DID NOT REAPPEAR WHEN EXTRANEAL VIAFLEX AND PHYSIONEAL, UNSPECIFIED PRODUCT THERAPIES WERE RE-INTRODUCED. ON (B)(6) 2010, THE PATIENT COMPLETED TAKING FENISTIL AND PREDNISOLONE. IT WAS NOT REPORTED IF THE EVENT OF UNSPECIFIED ALLERGY RESOLVED.

    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 42 YR Required Intervention EXTRANEAL VIAFLEX, PHYSIONEAL,FENISTIL| PREDNISOLONE