BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1932342 · Received December 17, 2010

    Report

    Report Number
    1423500-2010-07008
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 24, 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 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 FROM (B)(6) OF STERILE PERITONITIS IN A PATIENT WHILE RECEIVING PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6) 2010, THE PATIENT PRESENTED WITH CLOUDY EFFLUENT BUT WAS OTHERWISE ASYMPTOMATIC. THE PATIENT WAS DIAGNOSED WITH STERILE PERITONITIS AND RECEIVED TREATMENT WITH INTRAVENOUS (IV) VANCOMYCIN AND ORAL (PO) GENTAMICIN AS REMEDIAL MEDICATION AND THE EFFLUENT CLEARED "QUICKLY." ON (B)(6) 2010, TREATMENT WITH VANCOMYCIN WAS STOPPED, HOWEVER, THE PATIENT'S EFFLUENT BECAME CLOUDY AGAIN ON THE SAME DAY. IT WAS NOT REPORTED WHETHER TREATMENT WITH GENTAMICIN WAS STOPPED. ON AN UNREPORTED DATE IN (B)(6) 2010, THE PATIENT RECOVERED FROM THE SECOND EPISODE OF PERITONITIS. THE NURSE CONSIDERED THE SECOND EPISODE TO BE A "RELAPSE" OF THE FIRST EPISODE. EXTRANEAL THERAPY REMAINED ONGOING. ACTION TAKEN WITH DIANEAL PD4 UNKNOWN BAG WAS NOT REPORTED. THE NURSE CONSIDERED THE STERILE PERITONITIS/CLOUDY EFFLUENT TO BE POSSIBLY RELATED TO THE USE OF EXTRANEAL FOR AS PATIENT PRESENTED WITH ASEPTIC PERITONITIS FOLLOWING OVERNIGHT USE OF EXTRANEAL. THE NURSE DID NOT CONSIDER DIANEAL PD4 UNKNOWN BAG TO BE A SUSPECT PRODUCT. THE REPORTING NURSE FURTHER STATED THAT, THE PATIENT HAD VERY GOOD STERILE TECHNIQUE AND THAT SHE WOULD BE SURPRISED IF THE PERITONITIS HAD BEEN CAUSED BY TOUCH CONTAMINATION. DESPITE THE DIAGNOSIS OF STERILE PERITONITIS SHE STATED THAT IS WAS VERY LIKELY THAT THERE WAS A MICROBIAL CAUSE.

    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 69 YR Required Intervention DIANEAL PD4 1.36% AND 2.27% AND EXTRANEAL