BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3170798 · Received June 14, 2013

    Report

    Report Number
    1416980-2013-15418
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 24, 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). THE PATIENT'S DATE OF BIRTH WAS UNKNOWN, HOWEVER IT WAS REPORTED THE PATIENT WAS BORN IN 1973. 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE PATIENT'S TREATMENT WITH CEFAZOLIN AND GENTAMYCIN DRUGS WAS DISCONTINUED. ON AN UNREPORTED DATE, THE PATIENT HAD CLOUDY FLUID AGAIN AFTER THE TREATMENT WAS STOPPED; THEREFORE, THE TREATMENT WITH ANTIBIOTICS CEFAZOLIN (2GM, PER DAY) AND GENTAMYCIN (40MG, 2 TIMES PER DAY) (ROUTES NOT REPORTED) WAS INITIATED AGAIN FOR PERITONITIS. THE TREATMENT WITH ANTIBIOTICS WAS CONTINUED UNTIL THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AT WHICH POINT THEY WERE CONSIDERED TO HAVE RECOVERED FROM THE REPORTED EVENT. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL THERAPY FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). DIANEAL THERAPY WAS ONGOING. THE PATIENT EXPERIENCED PERITONITIS MANIFESTED BY ABDOMEN PAIN AND CLOUDY PD FLUID. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE CAUSE OF PERITONITIS WAS NOT REPORTED. THE PATIENT WAS STARTED TREATMENT WITH CEFAZOLIN (2 GRAM, ONCE A DAY, AND IP) AND GENTAMYCIN (40 MG, TWICE PER DAY, AND IP) FOR PERITONITIS. THE PATIENT HAD NOT YET RECOVERED FROM THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272014 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL PD4 1.5%| DIANEAL PD4 2.5%