BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2061960 · Received April 19, 2011

    Report

    Report Number
    1423500-2011-04673
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 29, 2011
    Manufacturer
    BAXTER HEALTHCARE
    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. 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 BAXTER EMPLOYED NURSE FROM (B)(6) OF A BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE (DESCRIBED AS PATIENT MADE MISTAKE). ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS, NOT REQUIRING HOSPITALIZATION. ON (B)(6) 2011, THE PATIENT BEGAN REMEDIAL THERAPY WITH A LOADING DOSE OF VANCOMYCIN 1 GM, AND CONTINUING DAILY IP INJECTIONS OF TOBRAMYCIN 20MG AND ZIDIMET 1 GM. IT WAS NOT REPORTED WHETHER THE PATIENT WAS RE-TRAINED IN ASEPTIC TECHNIQUE, THEREFORE THE OUTCOME OF BREAK IN ASEPTIC TECHNIQUE WAS UNKNOWN. AT THE TIME OF THIS REPORT, THE EVENT OF PERITONITIS WAS RESOLVING. DIANEAL WAS ONGOING. THE NURSE BELIEVED THE EVENT OF PERITONITIS WAS UNRELATED TO DIANEAL PD2 ULTRABAG, HOWEVER DID NOT PROVIDE AN ASSESSMENT OF CAUSALITY FOR THE EVENT OF BREAK IN ASEPTIC TECHNIQUE. ON (B)(6) 2011, THE PATIENT ENDED REMEDIAL THERAPY WITH TOBRAMYCIN (20MG, DAILY, IP) AND ZIDIME (1GM, DAILY, IP). ON (B)(6) 2011, THE EVENT OF PERITONITIS RESOLVED WITH SEQUELAE.

    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 70 YR Required Intervention DIANEAL PD2 ULTRABAG