BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2162617 · Received July 14, 2011

    Report

    Report Number
    1423500-2011-09043
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 21, 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. THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS IS USE ERROR- POOR ASEPTIC TECHNIQUE.

    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 WITH CULTURE POSITIVE FOR GRAM POSITIVE ORGANISM IN A PATIENT COINCIDENT WITH DIANEAL PD2 ULTRABAG AND EXTRANEAL VIAFLEX THERAPIES FOR PERITONEAL DIALYSIS (PD). IN (B)(6) 2011, A BREAK IN ASEPTIC TECHNIQUE OCCURRED, DESCRIBED AS THE PATIENT MADE A MISTAKE. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. ON (B)(6) 2011, THE PATIENT RECEIVED REMEDIAL TREATMENT WITH A LOADING DOSE OF VANCOMYCIN (2 GM, IP) AND BEGAN TREATMENT WITH ZYENEM (125 MG, ONCE DAILY, IP). REMEDIAL TREATMENT WITH ZYENEM WAS ONGOING. THE PERITONITIS WAS RESOLVING AND THE PATIENT REMAINED HOSPITALIZED. THE OUTCOME OF THE BREAK IN ASEPTIC TECHNIQUE WAS NOT REPORTED. DIANEAL PD2 ULTRABAG AND EXTRANEAL VIAFLEX THERAPIES WERE ONGOING. THE NURSE BELIEVED THE PERITONITIS WAS UNRELATED TO DIANEAL PD2 ULTRABAG AND EXTRANEAL VIAFLEX THERAPIES. THE NURSE AND DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE BREAK IN ASEPTIC TECHNIQUE.

    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 52 YR Hospitalization| R EXTRANEAL VIAFLEX| DIANEAL PD2 ULTRABAG