BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRISMASATE BGK 4/2.5

    MDR report key: 701057 · Received April 12, 2006

    Report

    Report Number
    701057
    Event Type
    Other
    Date Received
    April 12, 2006
    Date of Event
    March 11, 2006
    Report Date
    April 12, 2006
    Manufacturer
    GAMBRO RENAL PRODUCTS, INC.
    Product Code
    FJK
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING THE HOURLY PRISMA CHECK, THE SICU NURSE DISCOVERED THAT 779 ML OF FLUID RATHER THAN 50 ML OF FLUID HAD BEEN REMOVED. RATE WAS SUPPOSED TO BE 50 ML PER HOUR. CVVHD (CONTINUOUS VENO-VENOUS HEMODIALYSIS) WAS STOPPED. THE DIALYSIS NURSE WAS CALLED, AND SHE FOUND THAT THE DIALYSATE BAG HAD BEEN IMPROPERLY SPIKED AND THE LUER LOCK WAS LOOSENED. THERE WAS DIALYSATE FLUID ON THE FLOOR. PHENYLEPHRINE DRIP WAS INCREASED IN ORDER TO KEEP THE PATIENT'S MEAN ARTERIAL PRESSURE ABOVE 60. THE MD WAS NOTIFIED, AND AFTER ASSESSING THE PATIENT, ORDERED A BOLUS OF NORMAL SALINE 250 ML. THAT RESULTED IN A MARGINAL INCREASE IN THE PATIENT'S BLOOD PRESSURE (WHICH HAD DROPPED TO THE 70'S SYSTOLIC). AN ATTEMPT WAS MADE TO DECREASE THE PHENYLEPHRINE DRIP A COUPLE OF HOURS LATER, BUT IT HAD TO BE INCREASED AGAIN TO KEEP THE MEAN ARTERIAL PRESSURE ABOVE 60. THE PHYSICIAN WAS AGAIN NOTIFIED AS THE PHENYLEPHRINE COULD NOT BE DECREASED TO HIS BASELINE AMOUNT WITHOUT HIS BLOOD PRESSURE DROPPING. ALBUMIN WAS ORDERED. PER THE SITE, THERE WERE NO ALARMS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMASATE BGK 4/2.5 DIALYSATE BAG, CRRT FJK GAMBRO RENAL PRODUCTS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR