BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1990829 · Received February 15, 2011

    Report

    Report Number
    1423500-2011-01966
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 22, 2011
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    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 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. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A CONSUMER FROM (B)(6) OF AREA NOT CLEAN BEFORE STARTING PERITONEAL DIALYSIS (PD) AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY. ON (B)(6) 2011, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 ULTRABAG THERAPY (DOSE AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). IN (B)(6) 2011, THE AREA WAS NOT CLEAN BEFORE STARTING PD AND ON (B)(6) 2011, THE PATIENT DEVELOPED PERITONITIS (MANIFESTATIONS NOT REPORTED). THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS. ON (B)(6) 2011, THE PATIENT RECEIVED REMEDIAL TREATMENT WITH A LOADING DOSE OF VANCOMYCIN (2 GM, IP) AND AMIKACIN (500 MG, IP). ON THE SAME DATE, THE PATIENT BEGAN REMEDIAL TREATMENT WITH VANCOMYCIN (1 GM, ONCE DAILY, IP) AND AMIKACIN (250 MG, ONCE DAILY, IP). THE PERITONITIS WAS RESOLVING. THE OUTCOME OF THE EVENT WAS NOT REPORTED. DIANEAL PD2 ULTRABAG THERAPY WAS ONGOING. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE REPORTER BELIEVED THE PERITONITIS WAS UNRELATED TO DIANEAL THERAPY AND REPORTED THE CAUSE OF THE PERITONITIS AS THE AREA WAS NOT CLEAN BEFORE STARTING PD. THE REPORTER DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENT.

    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 71 YR Required Intervention DIANEAL PD2 ULTRABAG