BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2151789 · Received July 6, 2011

    Report

    Report Number
    1423500-2011-08719
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 14, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 UNDETERMINED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV): THIS IS A SPONTANEOUS REPORT BY A NURSE WITH SUPPLEMENTAL INFORMATION BY A CONSUMER FROM (B)(6) OF INFECTION, SEVERE STOMACH CRAMPS, HEADACHES AND RECURRENT PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX AND EXTRANEAL VIAFLEX THERAPIES. ON AN UNREPORTED DATE, THE PATIENT CONTACTED BAXTER'S TECHNICAL SERVICE (BTS) CENTER TO REQUEST ASSISTANCE ON THE HOMECHOICE (HC) DEVICE. THE PATIENT REPORTED EXPERIENCING AN INFECTION BUT WAS UNSURE WHETHER IT WAS FROM A BUG BITE. THE PATIENT RECEIVED ANTIBIOTICS. A FOLLOW-UP CALL WAS MADE TO THE PATIENT'S NURSE. ACCORDING TO THE NURSE, ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED HEADACHES AND SEVERE STOMACH CRAMPS, A CLOUDY BAG, AND RECURRENT PERITONITIS WITH CULTURE POSITIVE FOR ACINETOBACTER,. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR THE EVENTS OF RECURRENT PERITONITIS AND HEADACHES. A COMPUTERIZED TOMOGRAPHY (CT) WAS PERFORMED DUE TO THE HEADACHES AND AT THE TIME OF THIS REPORT, THE RESULTS WERE NOT AVAILABLE. THE PATIENT WAS TREATED WITH VANCOMYCIN . ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THE RECURRENT PERITONITIS AND HEADACHES. IT WAS UNKNOWN WHETHER THE SEVERE STOMACH CRAMPS AND INFECTION RESOLVED. THE NURSE WAS UNAWARE OF THE NEW INFECTION THAT THE PATIENT HAD DUE TO THE BUG BITE. DIANEAL PD4 AMBUFLEX AND EXTRANEAL VIAFLEX WERE CONTINUED. THE REPORTER BELIEVED THE EVENTS OF RECURRENT PERITONITIS AND HEADACHES WERE NOT RELATED TO DIANEAL PD4 AMBUFLEX AND EXTRANEAL VIAFLEX. CAUSALITY FOR THE EVENTS OF SEVERE STOMACH CRAMPS AND INFECTION WERE 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 Hospitalization DIANEAL PD4 AMBUFLEX| EXTRANEAL VIAFLEX