BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1961894 · Received January 14, 2011

    Report

    Report Number
    1423500-2011-00666
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 20, 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 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR 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 NURSE FROM (B)(6) OF STERILE PERITONITIS IN A (B)(6) MALE PATIENT DURING TREATMENT WITH DIANEAL UNKNOWN BAG AND EXTRANEAL VIAFLEX THERAPIES. ON (B)(6) 2010, THE PATIENT EXPERIENCED STERILE PERITONITIS MANIFESTED BY CLOUDY EFFLUENT. THE PATIENT RECEIVED TREATMENT WITH UNSPECIFIED ANTIBIOTIC THERAPY PER HOSPITAL PROTOCOL. AT THE TIME OF THIS REPORT, THE STERILE PERITONITIS WAS RESOLVING AND THE "BAGS WERE STILL CLEARING." THERAPY WITH EXTRANEAL CONTINUED. THE ACTION TAKEN WITH DIANEAL WAS NOT REPORTED. THE NURSE DID NOT PROVIDE A CAUSALITY ASSESSMENT FOR THE STERILE PERITONITIS TO DIANEAL AND EXTRANEAL VIAFLEX THERAPIES. ADDITIONAL INFORMATION ((B)(4) 2010): ON (B)(6) 2009, THE PATIENT BEGAN TREATMENT WITH DIANEAL UNKNOWN BAG AND EXTRANEAL VIAFLEX IP FOR APD. ON AN UNREPORTED DATE ((B)(6) 2010 DELIVERY), THE PATIENT BEGAN TREATMENT WITH DIANEAL UNKNOWN BAG 1.36% (LOT NUMBER 10G06930) AND 2.27% (LOT NUMBER 10E05930) AND EXTRANEAL VIAFLEX (LOT NUMBERS 10F27937 AND 10I17937) IP FOR APD. ON (B)(6) 2010, THE PATIENT EXPERIENCED STERILE PERITONITIS MANIFESTED BY CLOUDY EFFLUENT. THE PATIENT RECEIVED TREATMENT WITH PERITONITIS PROTOCOL AND DID NOT REQUIRE HOSPITALIZATION. ON (B)(6) 2010, THE PATIENT BEGAN TREATMENT PER PROTOCOL WITH VANCOMYCIN 2 GRAM ONCE WEEKLY (GIVEN UNTIL (B)(6) 2010) AND CEFTAZIDIME 1.5 GRAMS DAILY IP WITH THE LAST FILL ON APD (TO BE GIVEN UNTIL (B)(6) 2010). THE OUTCOME OF THE STERILE PERITONITIS WAS REPORTED AS ONGOING AND IMPROVED. THERAPY WITH DIANEAL AND EXTRANEAL CONTINUED. THE REPORTER CONSIDERED THE EVENT TO BE MILD IN SEVERITY BUT DID NOT PROVIDE A CAUSALITY ASSESSMENT FOR THE STERILE PERITONITIS TO DIANEAL UNKNOWN BAG AND EXTRANEAL VIAFLEX THERAPIES. ADDITIONAL INFORMATION ((B)(4) 2010): THE PATIENT HAS STOPPED DIANEAL AND EXTRANEAL 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 80 YR Required Intervention