BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIALYSIS

    MDR report key: 1941469 · Received December 13, 2010

    Report

    Report Number
    1941469
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    November 2, 2010
    Report Date
    December 13, 2010
    Manufacturer
    FRESENIUS
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT RECEIVED THREE AND A HALF HOURS OF HEMODIALYSIS. THE PRE DIALYSIS LABS WERE AS FOLLOWS: NA 141, K 4.8, BUN 54, CR 8.2. POST DIALYSIS LABS WERE AS FOLLOWS: BUN 19, PHOS 3.0, NA 128, K 4.9. THE NEXT SET OF LABS WERE: PHOS 6.5, K 6.1, NA 126. THE PT WAS MEDICALLY TREATED WITHOUT ANY NEGATIVE OUTCOMES. DIALYSIS WAS SUBSEQUENTLY PERFORMED TO FURTHER CORRECT LABS. THE MACHINE WAS PULLED TO HAVE BIOMED VERIFY CALIBRATION OF PUMPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIALYSIS DIALYSIS KDI FRESENIUS 2008K *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR DIALYSIS