BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3150688 · Received June 6, 2013

    Report

    Report Number
    1416980-2013-14531
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 14, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): FOLLOW-UP INFORMATION WAS OBTAINED RELATED TO THE EVENT. IT WAS REPORTED THAT THE PATIENT WAS ALSO TREATED WITH VANCOMYCIN 1G/DAY AND AMIKACIN 300MG/DAY FOR THE PERITONITIS. THE PATIENT WAS LATER DISCHARGED FROM THE HOSPITAL BUT STILL NOT RECOVERED FROM THE PERITONITIS. EIGHT DAYS LATER, THE PATIENT EXPERIENCED CLOUDY EFFLUENT AND ABDOMINAL PAIN. THE PATIENT WAS AGAIN HOSPITALIZED FOR THE PERITONITIS AND TREATED WITH VANCOMYCIN AND AMIKACIN. AT THE TIME OF THE REPORT, THE PATIENT HAD NOT YET RECOVERED FROM THE PERITONITIS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXACT AGE AT THE TIME OF THE EVENT IS UNKNOWN. HOWEVER, THE PATIENT WAS BORN IN 1955. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL FOLLOW UP INFORMATION WAS RECEIVED FROM THE NURSE. IT WAS REPORTED THAT THE PATIENT DISCONTINUED THE TREATMENT WITH VANCOMYCIN AND AMIKACIN AFTER 21 DAYS OF TREATMENT. THE NEXT DAY, THE PATIENT'S PD CATHETER WAS REMOVED AND THE PD THERAPY WAS DISCONTINUED. THE PATIENT WAS HOSPITALIZED FOR 37 DAYS BEFORE BEING DISCHARGED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD). DIANEAL PD4 1.5% REMAINED ONGOING AND UNCHANGED. THE PATIENT EXPERIENCED PERITONITIS, MANIFESTED BY CLOUDY EFFLUENT AND ABDOMINAL PAIN. THE PATIENT WAS HOSPITALIZED AND STARTED REMEDIAL TREATMENT IP WITH CEFAZOLIN 1G 2X/DAY AND GENTAMYCIN 40MG 2X/DAY. THE EVENT PROLONGED HOSPITALIZATION. THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251169 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL PD4 1.5%