BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1550 HEMODIALYSIS MACHINE

    MDR report key: 309115 · Received December 14, 2000

    Report

    Report Number
    1423500-2000-01270
    Event Type
    Injury
    Date Received
    December 14, 2000
    Date of Event
    October 19, 2000
    Report Date
    November 17, 2000
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FKP
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    BAXTER HEALTHCARE RECIVED FACILITY USER MEDWATCH REPORT #192504-2000-0001 REPORTING: "DURING REINFUSION, AIR DETECTOR ALARM ACTIVATED. CARETAKER COULD VISUALIZE NO AIR IN LINES OR DRIP CHAMBER. RESET BUTTON PRESSED. AIR NOTED EMERGING FROM CHAMBER AT THAT TIME AND SUSPICION THAT AIR EMBOLISM MAY HAVE BEEN DELIVERED TO PT. UPON EVAL OF MACHINE, NOTED THAT SPRING HOLD DRIP CHAMBER WAS LOOSE." FOLLOW UP WITH ACCOUNT ON 12/12/00: HEALTHCARE PROFESSIONAL (HCP) REPORTED THIS EVENT OCCURRED DURING THE RINSEBACK OF NORMAL SALINE AT THE END OF TREATMENT. PT (PT) HAS RIGHT SUBCLAVIAN ACCESS. PT EXHIBITED SHORTNESS OF BREATH, DISORIENTATION AND DECREASED BLOOD PRESSURE. HCP PLACED PT ON LEFT SIDE IN TRENDELENBURG POSITION AND ADMINISTERED 2 LITERS OXYGEN VIA MASK. PT WAS TRANSFERRED TO HOSP FOR 23 HOURS OBSERVATION AND DISCHARGED. MEDICAL INTERVENTION ADMINISTERED DURING OBSERVATION WAS NOT AVAILABLE. AS OF 12/12/00, HCP REPORTED PT IS FEELING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1550 HEMODIALYSIS MACHINE SPS 1550 FKP BAXTER HEALTHCARE CORP. 1550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1