BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 1000 SPDS

    MDR report key: 531498 · Received March 3, 2004

    Report

    Report Number
    1423500-2004-00195
    Event Type
    Malfunction
    Date Received
    March 3, 2004
    Date of Event
    February 5, 2004
    Report Date
    February 5, 2004
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A DIALYSIS FACILITY NURSE REPORTED THAT MORE ULTRAFILTRATION (UF) WAS REMOVED THAN INTENDED DURING A PT TREATMENT ON A SYSTEM 1000 HEMODIALYSIS MACHINE. THE UF GOAL WAS 3.0 KG OVER A 4 HR TREATMENT, HOWEVER, 4.6 KG WERE REMOVED IN ONE HR AND 25 MINS. IT WAS REPORTED THAT ONE HR AND TWENTY-FIVE MINS AFTER THE START OF TREATMENT, THE PT'S BLOOD PRESSURE (BP) FELL RAPIDLY FROM 140/57 TO 83/42 AND THEIR PULSE RATE ELEVATED TO 123. THE PT STARTED TO COMPLAIN OF NOT FEELING WELL, AND OF FEELING WARM. THE PT'S BP CONTINUED TO FALL TO 77/45 AND PT COMPLAINED FURTHER OF BEING VERY HOT. THE PT WAS IN THE TRENDELENBERG POSITION AND WAS ADMINISTERED SALINE AND OXYGEN AT 5L PER MIN. THE PT WAS NOTED TO BE DIAPHORETIC AND COOL. THE PT LOST CONSCIOUSNESS AND THE CHAIR FOOT WAS ELEVATED MANUALLY, PLACING THE PT IN DEEP TRENDELENBERG. THE PT'S BP WAS 56/41. THE "CRASH" CART WAS CALLED FOR AND DEFIBRILLATOR PADS WERE APPLIED. ONE LITER OF SALINE WAS COMPLETED AND ANOTHER LITER WAS STARTED. THE RHYTHM ON THE DEFIBRILLATOR MONITOR WAS SINUS AND 60 BPM. THE PT HAD EVEN RESPIRATIONS. HOWEVER, THE PT WAS NOT RESPONDING AND THEREFORE 911 AND THE DR WAS CALLED. THE PT'S BP WAS 87/49. THE PT'S FEET WERE LOWERED, AND A 12 LEAD ECG WAS OBTAINED. FIRST RESPONDERS FROM EMS ARRIVED BUT BY THAT TIME THE PT WAS STABILIZED, ORIENTED AND TALKING. THE PT WAS ASSESSED BY THE DR AND FOUND TO BE CLINICALLY STABLE. THE PT WAS DISCHARGED TO GO HOME IN NO ACUTE DISTRESS AND FELT "GOOD". TREATMENT PARAMETERS CONSISTED OF A 450 ML/MIN BLOOD FLOW RATE AND 800 ML/MIN DIALYSIS FLOW RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 1000 SPDS HEMODIALYSIS MACHINE FKP BAXTER HEALTHCARE CORPORATION SYSTEM 1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention