BEUDAMED
    FDA Adverse Event Death Summary report: N

    GISH

    MDR report key: 23468 · Received December 9, 1994

    Report

    Report Number
    1123359-1994-00003
    Event Type
    Death
    Date Received
    December 9, 1994
    Date of Event
    November 17, 1994
    Report Date
    November 22, 1994
    Manufacturer
    GISH BIOMEDICAL
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AT 13:00 ON FRIDAY, NOV, 18, 1994 AN INCIDENT WAS REPORTED TO KOL WHERE GISH TUBING HAD SEPERATED FROM THE DISTAL END OF THE SARN TEMP PROBE ON A CUSTOM ECMO PACK IN PT DEATH. THERE WAS NO INDICATION FROM REPORTER THAT THE GISH PRODUCT WAS DEFECTIVE OR THE CAUSE OF THE INCIDENT. PRODUCT WAS TAKEN TO RISK MANAGEMENT AND ALLPARTIES INVOLVED WERE NOTIFIED. THE TEMP PROBE & TUBING WERE ISOLATED FOR INSPECTION. AT THIS TIME THE STOCKED/SHILEY PUMP IS BEING EXAMINED FOR PERFORMANCE PARAMETERS. A DETAILED REPORT WILL NOT BE AVAILABLE UNTIL MONDAY 11/21/94. PT WAS ON ECMO 11 DAYS. ALL CIRCUIT TUBING HAD JUST BEEN CHANGED SIX HOURS PRIOR TO INCIDENT. NOTHING UNUSUAL IN THE PRIMING OR SET-UP, AND NOTHING REMARKABLE. DURING THE 6 HRS. PRIOR TO INCIDENT, FLOW WERE NORMAL USING STOCKERT/SHILEY PUMP & ARTEREIAL CANNULA. REPORTER WAS NOT SURE EXACTLY WHAT CAUSED THE INCIDENT. PRESSURES WERE NORMAL @ 250/150. PRE/PUST OXYGENATOR. PRESSURE ALARMS SOUNDED @ 400-500 MZ HG. BETWEEN 1 TO 1-1/2 MINUTES AFTER ALARM SOUNDED. THE SEPERATION OCCURED AT DISTAL END OF TEMP PROBE. REPORTER INDICATED THAT IN THEIR EXPERIENCE, HIGH LINE PRESSURES WERE COINCIDENTAL WITH THE APPERANCE OF SOME SMALL LEAKS AT VARIOUS CONNECTION SITES. IN THIS INCIDENT, NO LEAKS WERE NOTICED PRIOR TO OCCURRENCE. PHONE CONVERSATION WITH REPORTER AT 3:16 AND 3:40 PM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GISH LONG TERM PERFUSION KIT FRN GISH BIOMEDICAL GS63240 263415

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Death STOCKERT SHILEY ROLLER PUMP