BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2051573 · Received April 12, 2011

    Report

    Report Number
    1423500-2011-04389
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 25, 2011
    Manufacturer
    BAXTER HEALTHCARE
    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 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. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER FROM (B)(6) OF A BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG THERAPY FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, A BREAK IN ASEPTIC TECHNIQUE OCCURRED, FURTHER DESCRIBED AS PATIENT MADE A MISTAKE AND DID NOT CLEAN AREA BEFORE STARTING PD. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. HOSPITALIZATION WAS NOT REQUIRED. ON AN UNREPORTED DATE, THE PATIENT RECEIVED VANCOMYCIN (2 GM, IP, EVERY 7TH DAY ONE BAG), HEPARIN (1000 IU, IP,EVERY EXCHANGE), TOBRAMYCIN (16 MG, IP, PER BAG) AND "RRETLINE" (250MG, IP, PER BAG). AT THE TIME OF REPORTING, THE EVENT OF PERITONITIS WAS RESOLVING. IT WAS NOT REPORTED IF THE PATIENT RECEIVED RE-TRAINING REGARDING ASEPTIC TECHNIQUE, THEREFORE AN OUTCOME FOR THE EVENT OF BREAK IN ASEPTIC TECHNIQUE WAS NOT REPORTED. DIANEAL PD2 ULTRABAG THERAPY CONTINUED. THE CONSUMER BELIEVED THAT DIANEAL PD4 ULTRABAG THERAPY WAS UNRELATED TO THE PERITONITIS. AN ASSESSMENT OF CAUSALITY FOR THE EVENT OF BREAK IN ASEPTIC TECHNIQUE WAS NOT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention DIANEAL PD2 ULTRABAG