BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1896883 · Received November 11, 2010

    Report

    Report Number
    1423500-2010-05621
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 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 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 SPONTANEOUS REPORT BY A BAXTER (B)(4) FROM (B)(6) OF CONSTIPATION AND PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. IN 2010, THE PATIENT EXPERIENCED CONSTIPATION. ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS, REQUIRING HOSPITALIZATION. ON (B)(6) 2010, THE PATIENT WAS GIVEN A LOADING DOSE OF AMIKACIN 125MG IP AND VANCOMYCIN 1GM IP, AND STARTED ON FORTUM 1GM IP "THRICE" DAILY AND REFLIN 1GM IP "THRICE" DAILY. THE ROOT CAUSE OF THE PERITONITIS WAS CONSTIPATION. AT THE TIME OF REPORTING, THE PATIENT REMAINED HOSPITALIZED, THE EVENT OF PERITONITIS WAS RESOLVING AND THE PATIENT CONTINUED TO RECEIVE FORTUM AND REFLIN. IT WAS NOT REPORTED IF DIANEAL THERAPY CONTINUED, OR IF THE EVENT OF CONSTIPATION RESOLVED. THE NURSE BELIEVED THAT THE EVENT OF PERITONITIS WAS UNRELATED TO DIANEAL THERAPY. THE NURSE DID NOT REPORT IF THE EVENT OF CONSTIPATION WAS RELATED TO DIANEAL THERAPY.

    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 62 YR Hospitalization| R DIANEAL PD2 ULTRABAG