BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2161371 · Received July 13, 2011

    Report

    Report Number
    1423500-2011-09015
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 20, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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 THIS INCIDENT WAS DETERMINED TO BE USE ERROR-BREAK IN ASEPTIC TECHNIQUE.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A PHYSICIAN OF TOUCH CONTAMINATION AND PERITONITIS IN A FEMALE PATIENT IN HER (B)(6) COINCIDENT WITH EXTRANEAL VIAFLEX, DIANEAL-N PD4 1.5 AND DIANEAL-N PD4 2.5 THERAPIES. IN (B)(6) 2007, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX (1.5 LITERS, DAILY, LOT NUMBER NOT REPORTED), DIANEAL-N PD4 1.5 AND DIANEAL-N PD4 2.5 (DOSES, FREQUENCIES AND LOT NUMBERS NOT REPORTED) INTRAPERITONEALLY (IP) FOR CHRONIC RENAL FAILURE. ON AN UNREPORTED DATE IN 2011, THE PATIENT EXPERIENCED TOUCH CONTAMINATION. ON (B)(6) 2011, THE PATIENT CONTACTED BAXTER (B)(4) TECHNICAL SERVICE CENTER AND STATED THAT SHE EXPERIENCED PERITONITIS AND REQUIRED HOSPITALIZATION. IT WAS NOT REPORTED IF LABORATORY DATA OR DIAGNOSTIC WERE PERFORMED. ON AN UNREPORTED DATE, THE PATIENT BEGAN REMEDIAL THERAPY WITH CEFAMEZIN (DOSE, FREQUENCY AND ROUTE NOT REPORTED). THE ROOT CAUSE OF THE PERITONITIS WAS TOUCH CONTAMINATION. AT THE TIME OF THIS REPORT, EXTRANEAL VIAFLEX, DIANEAL-N PD4 1.5 AND DIANEAL-N PD4 2.5 THERAPIES WERE ONGOING AND THE EVENT OF PERITONITIS WAS RESOLVING. IT WAS NOT REPORTED IF THE EVENT OF TOUCH CONTAMINATION HAD RESOLVED. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PHYSICIAN CONSIDERED THE EVENT OF PERITONITIS TO BE UNRELATED TO EXTRANEAL VIAFLEX, DIANEAL-N PD4 1.5 AND DIANEAL-N PD4 2.5 THERAPIES. THE PHYSICIAN DID NOT PROVIDE AN ASSESSMENT OF CAUSALITY FOR THE EVENT OF TOUCH CONTAMINATION IN RELATIONSHIP TO EXTRANEAL VIAFLEX, DIANEAL-N PD4 1.5 AND DIANEAL-N PD4 2.5 THERAPIES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL-N PD4 1.5| EXTRANEAL VIAFLEX| DIANEAL-N PD4 2.5