BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSFER SET

    MDR report key: 3181113 · Received June 20, 2013

    Report

    Report Number
    1416980-2013-16073
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 29, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. SAME PATIENT AS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FURTHER INVESTIGATION IT WAS DETERMINED THAT THE EVENT OF PATIENT DEATH WAS REPORTED IN ERROR.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOT NUMBER H12J11037 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. AN EXCEPTION WAS NOTED FOR THE BATCH BUT DOES NOT INDICATE ANY ISSUES RELATED TO THE COMPLAINT.

    Additional Manufacturer Narrative · 1

    (B)(4). ON AN UNREPORTED DATE, THE PATIENT DIED. THE CAUSE OF DEATH WAS UNKNOWN. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THIS IS REPORT 4 OF 4. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS HOSPITALIZED FOR SIX DAYS. THE PATIENT WAS TREATED WITH CEFTAZIDIME (DOSE, ROUTE UNKNOWN). PD CATHETER PULLED AND THE PATIENT PLACED ON HEMODIALYSIS. PER THE RN AND PATIENT, NO DEFECTIVE PACKAGING OR DRY MINICAP WAS OBSERVED. THE CAUSE WAS UNKNOWN. PER THE RN, THESE EVENTS WERE UNRELATED TO BAXTER DEVICES OR SOLUTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280059 TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Death| H| R DIANEAL LOW CAL