BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLO-GARD 6200 VOLUMETRIC INFUSION PUMP

    MDR report key: 173353 · Received June 18, 1998

    Report

    Report Number
    6000001-1998-00418
    Event Type
    Death
    Date Received
    June 18, 1998
    Date of Event
    December 1, 1997
    Report Date
    May 21, 1998
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE INFUSION PUMP CATALOG NUMBER WAS MOST LIKELY 2M8048. IT WAS REPORTED IN THE PREVIOUS MDR AS 2M8043.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A PHARMACY JOURNAL THAT A LAWSUIT WAS FILED BY THE FAMILY OF A WOMAN WHO DIED LAST DECEMBER AFTER UNDERGOING SURGERY TO REPAIR AN ABDOMINAL AORTIC ANEURYSM. THE SUIT IS CHARGING THAT THE PT'S DEATH WAS DUE TO AN OVERDOSE OF NIPRIDE WHICH OCCURRED AFTER THE TUBING FOR THE DRUG WAS REMOVED FROM THE PUMP WITHOUT THE "GRAVITY CLAMP" BEING ENGAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLO-GARD 6200 VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. 6300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR