BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLOSED APHERESIS KIT, PL3014, SAMPLE POUCH AMS

    MDR report key: 82794 · Received April 8, 1997

    Report

    Report Number
    2314912-1997-00008
    Event Type
    Malfunction
    Date Received
    April 8, 1997
    Date of Event
    March 28, 1997
    Report Date
    April 1, 1997
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    GKT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 3/28/97 DURING A STEM CALL COLLECTION PROCEDURE USING THE CS-3000 PLUS BLOOD CELL SEPARATOR, THE OPERATOR NOTICED AFTER 2 L OF WHOLE BLOOD PROCESSED, APPROX. HALF HR AFTER THE PROCEDURE HAD STARTED, THAT THE PUMP HANDLE HAD BEEN LEFT OPEN. THIS CAUSED THE PT TO RECEIVE AN EXCESS OF ACD SOLUTION. IN HALF HR THE ACD BAG SHOWED THAT 657 ML HAD BEEN USED. THE PROCEDURE WAS BEING RUN AT RATIO OF 12:1. THE PT COMPLAINED OF TIGHTNESS OF THE CHEST AND TINGLING OF THE BODY. THE PROCEDURE WAS IMMEDIATELY DISCONTINUTED AND THE MACHINE PLACED ON HALT/IRRIGATE FOR 30 MINUTES. APPROX. 1 L OF SALINE WAS GIVEN TO THE PT TO MINIMIZE THE REACTION. NO MEDICATION WAS GIVEN (THE PT HAD BEEN GIVEN OXICAL AT THE ONSET OF THE PROCEDURE PER THE DEPTS PROCEDURE). THE PROCEDURE WAS COMPLETED AND A TOTAL OF 10 L OF WHOLE BLOOD WAS PROCESSED AT A RATIO OF 13:1. THE PT WAS RELEASED IN GOOD CONDITION FROM THE APHERESIS ROOM BACK TO HER HOSPITAL BED WHERE SHE WAS ALREADY AN INPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLOSED APHERESIS KIT, PL3014, SAMPLE POUCH AMS CLOSED APHERESIS KIT, PL3014, SAMPLE POUCH AMS GKT BAXTER HEALTHCARE CORP. NA H97A17014

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other