BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4222997 · Received November 4, 2014

    Report

    Report Number
    1416980-2014-38649
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 8, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TRANSFER SET. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, THEREFORE, A DEVICE ANALYSIS CANNOT BE COMPLETED. THE CAUSE IS NOT IDENTIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT PERFORMED AUTOMATED PD THERAPY AT NIGHT AND CONTINUOUS AMBULATORY PD THERAPY DURING THE DAY. THE CAUSE OF PERITONITIS WAS UNKNOWN. THE PERITONITIS WAS MANIFESTED BY GREENISH BLACK PD EFFLUENT. ON THE SAME DAY AS ONSET, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. ON AN UNKNOWN DATE, THE PATIENT STARTED TREATMENT FOR THE PERITONITIS WITH UNSPECIFIED ANTIBIOTICS ORALLY AND INTRAVENOUSLY WITH (IV) VANCOMYCIN, IV FLAGYL, IV CEFTAZIDIME (DOSES AND FREQUENCIES NOT REPORTED). AT THE TIME OF THIS REPORT, THE ANTIBIOTIC TREATMENT WAS ONGOING. TWENTY DAYS AFTER ONSET OF THE PERITONITIS, THE PATIENT¿S PD CATHETER WAS REMOVED AND ONE DAY LATER, THE PATIENT WAS STARTED ON HEMODIALYSIS (HD). AT THE TIME OF THIS REPORT, THE PATIENT WAS REPORTEDLY STILL HOSPITALIZED AND HD THERAPY WAS ONGOING. AT THE TIME OF THIS REPORT, THE PERITONITIS WAS RESOLVING AND THE PATIENT WAS RECOVERING FROM THE PERITONITIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 5 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708261 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R DIANEAL PD4, 1.5% & 2.5% AMBUFLEX, EXTENSION SET| TITANIUM ADAPTER, CASSETTE, MINICAP, HOMECHOICE