BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CGH CENTRYSYSTEM 2

    MDR report key: 67839 · Received December 31, 1996

    Report

    Report Number
    67839
    Event Type
    Injury
    Date Received
    December 31, 1996
    Date of Event
    September 16, 1996
    Report Date
    September 23, 1996
    Manufacturer
    COBE LABORATORIES
    Product Code
    FKP
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DIALYSIS WAS INITIATED AND THE AIR DETECTOR BEGAN ALARMING. THE ALARM WAS RESET A NUMBER OF TIMES AND WAS EVENTUALLY TURNED OFF BY THE TECH. THE VENOUS BLOODLINE WAS REMOVED FROM THE LINE CLAMPS. IT IS NOT CLEAR WHEN THE BLOOD PUMP WAS STOPPED. AIR WAS NOTED IN THE VENOUS LINE BELOW THE AIR DETECTOR. THE SALINE BAG WAS EMPTY ALLOWING AIR TO ENTER THE BLOODLINES AND DIALYZER. THE PT COMPLAINED OF CHEST PAIN, SOB AND A NUMB SENSATION. THE PT WAS PLACED ON HIS LEFT SIDE/TRENDELENBURG POSITION AND GIVEN O2. THE PT WAS TRANSPORTED TO THE HOSP FOR FURTHER EVALUATION AFTER DIALYSIS WAS TERMINATED. DEVICE AGE 5000 HRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CGH CENTRYSYSTEM 2 HEMODIALYSIS MACHINE FKP COBE LABORATORIES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| L| O| R 1) NMC ARTERIAL LINE 23-7205-2| 4) ACID CONCENTRATE #4018 NMC| 3) FRESENIUS F80B DIALYZER| 2) NMC VENOUS LINE 03-73/4-2| 5) NMC BICARB 4000 SERIES