BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3170228 · Received June 14, 2013

    Report

    Report Number
    1416980-2013-15376
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 23, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP INFORMATION: FIVE DAYS AFTER HOSPITALIZATION, GENTAMYCIN, AND VANCOMYCIN WERE STOPPED AND THE PATIENT WAS TREATED WITH TIENAM (500 MILLIGRAM (MG), 3 TIMES PER DAY, INTRAPERITONEAL INJECTION (IP) AND TOBRAMYCIN (80 MG, 4 TIMES PER DAY, IP) FOR PERITONITIS UNTIL THE PATIENT WAS DISCHARGED. CIPROFLOXACIN WAS ONGOING. TWENTY FIVE DAYS AFTER HOSPITALIZATION, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT RECOVERED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT'S DATE OF BIRTH WAS UNKNOWN, HOWEVER IT WAS REPORTED THE PATIENT WAS BORN IN 1953 BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE CAUSE OF PERITONITIS WAS NOT REPORTED. THE PATIENT WAS TREATED WITH GENTAMYCIN (80MILLIGRAM (MG), 4 TIMES/DAY), VANCOMYCIN (200MG, 50MG 4 TIMES/DAY), CIPROFLOXACIN (200MG, 50MG 4 TIMES/DAY) INTRAPERITONEALLY (IP) FOR PERITONITIS. THE PATIENT WAS RECOVERING FROM THE EVENT OF PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271444 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

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