BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3000310 · Received March 12, 2013

    Report

    Report Number
    1416980-2013-05912
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    January 10, 2013
    Report Date
    February 19, 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). ADDITIONAL INFORMATION RECEIVED FROM A HEALTH PROFESSIONAL: THE PATIENT WAS HOSPITALIZED AGAIN FOR PERITONITIS. THE PATIENT HAD SURGERY FOR CATHETER WITHDRAWAL AND DIANEAL THERAPIES WERE WITHDRAWN. THE PATIENT BEGAN TREATMENT WITH CEFAZOLINE (2GM, PER DAY, AND IP), GENTAMYCIN (80MG, PER DAY, AND IP) FOR PERITONITIS. THE PATIENT STOPPED TREATMENT WITH GENTAMYCIN AND BEGAN TREATMENT WITH VANCOMYCIN (1GM, PER DAY, AND IP) AND AMIKACIN (300MG, PER DAY, AND IP) FOR PERITONITIS. NINE DAYS LATER, THE PATIENT STOPPED TREATMENT WITH VANCOMYCIN AND AMIKACIN. THREE WEEKS LATER, THE PATIENT STOPPED TREATMENT WITH CEFAZOLIN. THE PATIENT HAD NOT YET RECOVERED FROM THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. 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. THE PROBLEM WAS NOT CONFIRMED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED. NO ASSIGNABLE CAUSE WAS DETERMINED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL THERAPIES FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). THE PATIENT WAS DIAGNOSED WITH PERITONITIS AND, TWO DAYS LATER, WAS HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH CEFAZOLINE (2GM/DAY, INTRA-PERITONEALLY (IP)) AND GENTAMYCIN (80MG/DAY, IP). THE CAUSE OF PERITONITIS WAS NOT REPORTED. DIANEAL THERAPIES WERE ONGOING. THE OUTCOME OF THIS PERITONITIS EVENT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103555 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

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