BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1911252 · Received December 1, 2010

    Report

    Report Number
    1423500-2010-06400
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 7, 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 AND LABELING 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 CONSTIPATION AND PERITONITIS IN A PATIENT FOLLOWING THE ADMINISTRATION OF PERITONEAL DIALYSIS (PD) THERAPY. ON AN UNREPORTED DATE IN 2010, THE PATIENT EXPERIENCED CONSTIPATION. ON (B)(6) 2010, THE PATIENT EXPERIENCED PERITONITIS. PER THE REPORTER, THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS. ON (B)(6) 2010, THE PATIENT RECEIVED LOADING DOSES OF VANCOMYCIN 1 GM IP AND CEFTAZIDIME 1 GM IP. ON THE SAME DAY, THE PATIENT ALSO BEGAN TREATMENT WITH AMIKACIN 100 MG IP ONCE DAILY, HEPARIN 2 ML IP ONCE DAILY, AND CEFTAZIDIME 250 MG IP ONCE DAILY. THE PATIENT WAS RECOVERING FROM THE PERITONITIS. THE OUTCOME FOR THE EVENT OF CONSTIPATION WAS NOT REPORTED. REMEDIAL TREATMENT WITH AMIKACIN, HEPARIN, AND CEFTAZIDIME WAS ONGOING. DIANEAL THERAPY WAS ONGOING. THE REPORTER BELIEVED THAT THE EVENT OF PERITONITIS WAS NOT RELATED TO DIANEAL THERAPY. THE REPORTER DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENT OF CONSTIPATION. THE REPORTER BELIEVED THE CAUSE OF THE PERITONITIS WAS CONSTIPATION.

    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 43 YR Required Intervention DIANEAL PD2 ULTRABAG