BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION SET

    MDR report key: 2024366 · Received March 19, 2011

    Report

    Report Number
    1423500-2011-03439
    Event Type
    Injury
    Date Received
    March 19, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOT (H10K12092) AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THAT LOT. BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THE CAUSE OF THIS INCIDENT COULD NOT BE DETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 3 OF 5 INVOLVED IN THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    THIS IS A NURSE REPORT FROM THE USA OF FOOD POISONING, GI PROBLEMS, AND PERITONITIS WITH CULTURE POSITIVE FOR STREPTOCOCCUS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX (DOSE, FREQUENCY, AND LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL TO BAXTER CUSTOMER SERVICE, THE PATIENT'S NURSE REPORTED THE FOLLOWING. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED GI PROBLEMS. ON (B)(6) 2011, THE PATIENT EXPERIENCED FOOD POISONING AND WAS SEEN IN THE EMERGENCY ROOM. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED DUE TO THE PERITONITIS. THE PERITONITIS WAS RELATED TO THE GI PROBLEMS. ON (B)(6) 2011, DIANEAL THERAPY WAS WITHDRAWN AND THE PATIENT RECEIVED REMEDIAL THERAPY WITH INTRAVENOUS (IV) VANCOMYCIN AND IV FORTAZ (DOSES AND FREQUENCIES NOT REPORTED) FOR THE PERITONITIS. TREATMENT FOR THE FOOD POISONING AND GI PROBLEMS WERE NOT REPORTED. IN (B)(6) 2011, DURING HOSPITALIZATION, HEMODIALYSIS WAS STARTED. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND WAS PLACED ON ORAL ANTIBIOTIC THERAPY (NAME, DOSE, AND FREQUENCY NOT REPORTED) AND PERMANENT HEMODIALYSIS. THE OUTCOMES FOR THE FOOD POISONING, GI PROBLEMS, AND PERITONITIS WERE NOT REPORTED. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE NURSE REPORTED THAT THE PERITONITIS WAS UNRELATED TO DIANEAL THERAPY AND DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE FOOD POISONING AND GI PROBLEMS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R DIANEAL PD4 AMBUFLEX