BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6000096-1999-00078

    MDR report key: 257432 · Received December 22, 1999

    Report

    Report Number
    6000096-1999-00078
    Event Type
    Malfunction
    Date Received
    December 22, 1999
    Date of Event
    November 10, 1999
    Report Date
    November 24, 1999
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DELAY OF VASOPRESSOR THERAPY DURING ALARM CONDITION REPORTED. A PT CAME IN TO THE EMERGENCY ROOM IN RESPIRATORY ARREST. DURING THE CODE PROCEDURE, NORMAL SALINE 1000CC WAS HUNG AT A WIDE OPEN RATE, AND DOPAMINE 400MG IN 250CC DEXTROSE 5% IN WATER STARTED AT 125CC/HR. WHILE TRYING TO START THE DOPAMINE INFUSION, THE NURSE REC'D AN UNSPECIFIED ALARM FROM THE PUMP WHICH REQUIRED SEVERAL TUBING CHANGES BEFORE THE PROBLEM WAS SOLVED. THE INFUSION WAS STARTED AND THE PT'S BLOOD PRESSURE WAS MAINTAINED AT AN ACCEPTABLE UNSPECIFIED LEVEL. THE PT WAS INTUBATED AND STABILIZED WITH A BLOOD PRESSURE OF 92/48 AND A PULSE OF 118. HE WAS THEN TRANSFERRED TO ANOTHER FACILITY WHERE HE LATER EXPIRED, "UNRELATED TO THIS INCIDENT". THE CLINICIANS ALSO HAD A PROBLEM STARTING A PERIPHERAL IV ACCESS WHICH CONTRIBUTED TO THE DELAY OF THE START OF THERAPY. THE PT REQUIRED AN INTERNAL JUGULAR LINE TO OBTAIN IV ACCESS.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other 1. UNSPECIFIED PLUM PUMP.