BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 6142451 · Received December 2, 2016

    Report

    Report Number
    1416980-2016-18003
    Event Type
    Injury
    Date Received
    December 2, 2016
    Report Date
    December 2, 2016
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MEAN AGE WAS 43.6 ± 13.0 YEARS. THE OCCURRENCE DATE IS BETWEEN (B)(6) 2009 AND (B)(6) 2011. THE REPORTER IS ALSO AFFILIATED WITH THE FOLLOWING INSTITUTION: (B)(6). ARTICLE CITATION: CHENG CHIA, LEE., KUN HUA, TU., HSIAO HUI, CHEN., MING YANG, CHANG., CHENG CHIEH, HUNG (2016). RISK FACTORS FOR DRAINAGE REQUIRING ASCITES AFTER REFRACTORY PERITONITIS IN PERITONEAL DIALYSIS PATIENTS. INT UROL NEPHROL (2016) 48:1721¿1730. DOI 10.1007/S11255-016-1376-Y. THE SAMPLE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER IS UNKNOWN, THEREFORE A DEVICE ANALYSIS COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED REFRACTORY PERITONITIS RESULTING IN SYMPTOMATIC ASCITES. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. THE PATIENT WAS HOSPITALIZED FOR THE EVENT AND WAS TREATED WITH UNSPECIFIED ANTIBIOTICS. ON AN UNREPORTED DATE THE PATIENT¿S PD CATHETER WAS REMOVED AND THE PATIENT WAS SWITCHED TO HEMODIALYSIS. SUBSEQUENTLY THE PATIENT DEVELOPED ASCITES REQUIRING PERCUTANEOUS DRAINAGE AND PROLONGED HOSPITALIZATION. THE PATIENT OUTCOME WAS NOT REPORTED. ADDITIONAL INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792220 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R EXTRANEAL