BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1940312 · Received December 29, 2010

    Report

    Report Number
    1423500-2010-07355
    Event Type
    Injury
    Date Received
    December 29, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 12, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. A BATCH REVIEW WILL NOT BE PERFORMED AS THE LOT NUMBER IS 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 EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    ON AN UNKNOWN DATE, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX (2L, DAILY) AND PHYSIONEAL, UNSPECIFIED PRODUCT 1.36% (4L, DAILY) AND 2.27% (2L, DAILY) , INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON (B)(6) 2010, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS, MANIFESTED BY ABDOMINAL PAIN, CLOUDY EFFLUENT AND MALAISE. ON (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH AMPICILLIN (DOSE AND FREQUENCY UNKNOWN) IP FOR PERITONITIS. AMPICILLIN WAS SUSPENDED AND THE PATIENT BEGAN TREATMENT WITH CEFAZOLINE (2G, DAILY, IP) FOR PERITONITIS. THE PHYSICIAN (PER THE NURSE) BELIEVED THAT THIS EVENT OF PERITONITIS WAS A RECURRENCE OF THE PREVIOUS EPISODE. ON AN UNREPORTED DATE IN DEC2010, THE PATIENT RECOVERED FROM THE EVENT OF PERITONITIS AND WAS DISCHARGED FROM THE HOSPITAL. AT THE TIME OF REPORTING, CEFAZOLINE REMAINED ONGOING. EXTRANEAL VIAFLEX AND PHYSIONEAL, UNSPECIFIED PRODUCT THERAPIES CONTINUED AT THE SAME DOSE. IT WAS NOT REPORTED IF THE EVENT OF MALAISE RESOLVED. THE NURSE STATED THAT THE PHYSICIAN THOUGHT THIS EPISODE OF PERITONITIS WAS A RECURRENCE AND THAT LABORATORY RESULTS OF THE PREVIOUS EPISODE OF PERITONITIS MAY HAVE BEEN MISTAKEN BECAUSE THE MICROORGANISMS WERE SIMILAR. THE NURSE BELIEVED THAT THE EVENT OF PERITONITIS WAS NOT RELATED TO EXTRANEAL VIAFLEX. THE NURSE DID NOT MENTION PHYSIONEAL, UNSPECIFIED PRODUCT IN THE CAUSALITY ASSESSMENT.

    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 71 YR Hospitalization| R UNSPECIFIED PRODUCT 2.27% (2L, DAILY)| UNSPECIFIED PRODUCT 1.36% (4L, DAILY)| EXTRANEAL VIAFLEX (2L, DAILY), PHYSIONEAL