BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6000096-1999-00081

    MDR report key: 257397 · Received December 22, 1999

    Report

    Report Number
    6000096-1999-00081
    Event Type
    Malfunction
    Date Received
    December 22, 1999
    Date of Event
    November 22, 1999
    Report Date
    November 22, 1999
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORT OF ONE DOCUMENTED AND ONE UNDOCUMENTED INCIDENT OF DELAY OF THERAPY DURING A PUMP ALARM CONDITION. IN THE DOCUMENTED INCIDENT, A PT WAS TO RECEIVE A NITROGLYCERIN DRIP FOR CHEST PAIN UNCONTROLLED BY SUBLINGUAL NITROGLYCERIN. THE NURSE SET UP THE DRIP (UNSPECIFIED AMOUNT AND RATE) AND ATTEMPTED TO START THE INFUSION. THE CLINICIAN REC'D AN UNSPECIFIED PUMP ALARM AND CHANGED MULTIPLE TUBINGS AND PUMPS OVER A PERIOD OF 10 MINUTESBEFORE THE INFUSION WAS ABLE TO BE STARTED. THE CUSTOMER STATES THAT THERE WAS NO PT HARM DUE TO THE REPORTED EVENT. NO FURTHER INFO WAS AVAILABLE. IF ADD'L INFO REGARDING THE OTHER INCIDENT BECOMES AVAILABLE, IT WILL BE FORWARDED TO THE AGENCY.

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other