BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1960338 · Received January 13, 2011

    Report

    Report Number
    1423500-2011-00557
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 21, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 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 STERILE PERITONITIS IN A PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX AND PHYSIONEAL, UNSPECIFIED PRODUCT THERAPIES. IN (B)(6) 2009, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX AND PHYSIONEAL, UNSPECIFIED PRODUCT (LOT NUMBER, DOSE AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY FOR AUTOMATED PERITONEAL DIALYSIS (PD) (OFF LABEL USE IN A PEDIATRIC PATIENT). ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH STERILE PERITONITIS MANIFESTED BY CLOUDY FLUID WITH WHITE CELLS REQUIRING HOSPITALIZATION. THE PATIENT DID NOT IMPROVE WITH DISCONTINUATION OF THE PD SOLUTION. ON (B)(6) 2010, THE PATIENT RECEIVED TREATMENT WITH VANCOMYCIN 30 MG/LITER AND CEFTAZIDIME 125 MG/LITER (GIVEN UNTIL (B)(6) 2010). ON (B)(6) 2010, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE OUTCOME WAS REPORTED AS ONGOING AND IMPROVED WITH ANTIBIOTICS CONTINUING (CLINICALLY RECOVERED). ACTION TAKEN WITH EXTRANEAL VIAFLEX AND PHYSIONEAL, UNSPECIFIED PRODUCT THERAPIES WAS NOT REPORTED. THE REPORTER ASSESSED THE SEVERITY OF THE STERILE PERITONITIS AS MODERATE AND DID NOT PROVIDE A CAUSALITY ASSESSMENT FOR THE STERILE PERITONITIS TO EXTRANEAL VIAFLEX AND PHYSIONEAL, UNSPECIFIED PRODUCT THERAPIES.

    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 5 YR Hospitalization| R CALCIUM CARBONATE, GENOTROPIN MINIQUICK,| FOLIC ACID AND SODIUM FEREDETATE| COLECALCIFEROL, ALFACALCIDOL, CINACALCET,| EXTRANEAL VIAFLEX AND PHYSIONEAL, RENAPRO ACBS,| NEORECORMON, POLYCAL ACBS, DUOCAL ACBS,| SODIUM CHLORIDE, KENDERGEN, PAEDIASURE PLUS RTH,