BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1923381 · Received December 13, 2010

    Report

    Report Number
    1423500-2010-06843
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 22, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 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 BAXTER EMPLOYED NURSE FROM (B)(6) OF STROKE, CONSTIPATION, AND PERITONITIS WITH CULTURE POSITIVE FOR E. COLI IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON AN UNREPORTED DATE THE PATIENT EXPERIENCED CONSTIPATION. ON (B)(6) 2010, THE PATIENT WAS HOSPITALIZED FOR A STROKE (ONSET DATE NOT REPORTED). ON (B)(6) 2010, WHILE HOSPITALIZED, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. ON (B)(6) 2010, THE PATIENT WAS GIVEN A LOADING DOSE OF VANCOMYCIN 1GM IP AND BEGAN TREATMENT WITH FORTUM 500MG IP TWO TIMES DAILY. ON (B)(6) 2010, THE PATIENT COMPLETED TAKING FORTUM AND BEGAN TREATMENT WITH DIANEAL PD2 ULTRABAG. ON (B)(6) 2010 THE PATIENT BEGAN TREATMENT WITH MEROPENUM 500MG IP ONCE DAILY. ON (B)(6) 2010, THE PATIENT COMPLETED TAKING MEROPENUM. ON (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH FLUCONAZOLE 100ML IV ONCE DAILY. ON (B)(6) 2010, THE PATIENT COMPLETED HIS TREATMENT WITH FLUCANOZOLE. THE ROOT CAUSE OF THE PERITONITIS WAS CONSTIPATION. AT THE TIME OF REPORTING, THE OUTCOME FOR THE EVENT OF PERITONITIS WAS NOT REPORTED, AND THE PATIENT REMAINED HOSPITALIZED. AN OUTCOME WAS NOT PROVIDED FOR THE EVENTS OF STROKE AND CONSTIPATION. ON (B)(6) 2010, THE PATIENT'S PERITONEAL DIALYSIS CATHETER WAS REMOVED AND DIANEAL THERAPY WAS DISCONTINUED. THE NURSE BELIEVED THAT THE EVENT OF PERITONITIS WAS UNRELATED TO DIANEAL THERAPY. THE NURSE DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENTS OF STROKE AND CONSTIPATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE KDJ: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R DIANEAL PD2 ULTRABAG