BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2200182 · Received August 10, 2011

    Report

    Report Number
    1423500-2011-10520
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 18, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOSPITAL CLARIFIED THAT THE SUSPECT PRODUCT TREATMENT SESSION FINISHED ON THE (B)(4) 2011 AT 9AM. THE PATIENT IS STILL RECEIVING TREATMENT WITH BOTH PHYSIONEAL AND EXTRANEAL. THE HOSPITAL STATED THAT THE PATIENT HAS RECOVERED.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 UNDETERMINED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SOLICITED REPORT BY A NURSE FROM (B)(6) OF A VERY ILL, FELT SLIGHTLY OFF AND SOMEWHAT UNWELL, AND PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) IN A PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX AND PHYSIONEAL THERAPIES FOR AUTOMATED PERITONEAL DIALYSIS (APD). ON (B)(6) 2011, WHEN DISCONNECTING FROM THERAPY THE PATIENT NOTICED A LOT MORE FLUID THAT NORMAL UNDERNEATH HIS PHYSIONEAL, UNSPECIFIED PRODUCT BAG AND EXTRANEAL VIAFLEX BAG. ON APPROXIMATELY (B)(6) 2011, THE PATIENT FELT SLIGHTLY OFF-FORM AND SOMEWHAT UNWELL. ON THE SAME DAY, THE PATIENT STOPPED PD THERAPY. ON (B)(6) 2011, THE PATIENT BECAME VERY ILL AND CONTACTED THE HOSPITAL. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS FROM AN UNREPORTED CAUSE AND WAS HOSPITALIZED. THE NURSE STATED THAT THE PATIENT'S TECHNIQUE IS VERY GOOD AND THAT HE DID NOT CONTAMINATE HIS LINE OR EQUIPMENT. THE NURSE ALSO STATED THAT THE PATIENT HAS HAD PROBLEMS WITH LEAKING BAGS IN THE PAST BUT THEY HAVE BEEN BAGS THAT HE WOULD HAVE NOTICED THE LEAK AS SOON AS HE OPENED THE WRAPPING. ON (B)(6) 2011, THE PATIENT BEGAN REMEDIAL THERAPY WITH VANCOMYCIN (30MGS/KG, FREQUENCY ACCORDING TO VANCOMYCIN LEVEL, IP). ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON AN UNREPORTED DATE IN 2011, THE EVENT OF PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) RESOLVED. REMEDIAL THERAPY WITH VANCOMYCIN WAS ONGOING AT THE TIME OF THIS REPORT AND WAS SCHEDULED TO END ON (B)(6) 2011. IT WAS NOT REPORTED WHETHER THE EVENTS OF VERY ILL, FELT SLIGHT OFF FORM AND SOMEWHAT UNWELL RESOLVED. EXTRANEAL VIAFLEX AND PHYSIONEAL THERAPIES WERE ONGOING. THE NURSE DID NOT PROVIDE A STATEMENT OF CAUSALITY FOR THE EVENTS OF VERY ILL, FELT SLIGHTLY OFF FORM AND SOMEWHAT UNWELL. THE NURSE STATED THAT THE EVENT OF PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) WAS POSSIBLY RELATED TO EXTRANEAL VIAFLEX AND PHYSIONEAL THERAPIES.

    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 53 YR Hospitalization| R EXTRANEAL VIAFLEX| PHYSIONEAL| UNSPECIFIED ORAL MEDICATION| PD CYCLER