BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4103547 · Received September 19, 2014

    Report

    Report Number
    1416980-2014-32496
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 27, 2014
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K894783
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED. THIS REPORT IS FOR AN UNKNOWN TITANIUM ADAPTER, (B)(4) ADDRESSES THE TRANSFER SET REPORT, (B)(4) ADDRESSES THE AUTOMATED PD SET WITH CASSETTE REPORT AND (B)(4) ADDRESSES THE MINICAP REPORT FOR THIS PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR THE REPORTED EVENT. THE TREATMENT FOR PERITONITIS WAS UNSPECIFIED ANTIBIOTICS (DOSAGE, ROUTE, AND FREQUENCY NOT REPORTED). THE CAUSE WAS REPORTED TO BE DUE TO THE PATIENT SWIMMING IN UNCLEAN WATER. WHILE IN THE HOSPITAL, THE PD CATHETER WAS REMOVED AND THE PATIENT WAS STARTED ON HEMODIALYSIS THERAPY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL SIX DAYS AFTER ADMISSION, BUT THEY HAD NOT YET RECOVERED FROM THE PERITONITIS. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THIS TIME. THIS IS REPORT 2 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585007 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization| R DIANEAL PD4 2.5% AMBUFLEX, HOMECHOICE| AUTOMATED PD SET WITH CASSETTE| TRANSFER SET, MINICAP