BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVI

    MDR report key: 56526 · Received August 16, 1996

    Report

    Report Number
    56526
    Event Type
    Injury
    Date Received
    August 16, 1996
    Date of Event
    June 18, 1996
    Report Date
    June 27, 1996
    Manufacturer
    3M AVI, INC.
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    OVER-INFUSION OF IVPB MEDICATION. PHYSICIAN'S ORDER FOR 6 GMS IGG4 TO RUN OVER 12 HRS. PHARMACY SENT DRUG MIXED IN 100 CC IV SOLUTION. NURSE HUNG SOLUTION AT 12:15 TO INFUSE AT 14 CC'S/HR. AT 2:30 PM THERE WERE 5-10 CC'S LEFT. AT THAT TIME SHE NOTED THE IV PUMP SAID THAT 34 CC'S HAD INFUSED. SHE CALLED THE CHARGE NURSE AND PHARMACIST AND CHECKED THE PT WHO SHOWED NO SIGNIFICANT CHANGES IN CONDITION. THE CHARGE NURSE REPORTED THAT THE IVPB HAD BEEN HUNG CORRECTLY. THE IVPB WAS INFUSING IN IVPB MODE WITH A 160 CC LIMIT AT 14 CC'S PER HR. THE PRIMARY RATE WAS 10 CC'S PER HR. THE PHARMACIST SAID THAT IT WAS LIKELY THAT THERE WAS SOME OVERFILL AND THAT AN APPROX VOLUME WAS SENT, HENCE THE 160 CC OF SOLUTION. PT'S CONDITION DID NOT CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVI INFUSION PUMP FRN 3M AVI, INC. AVI 480 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Life Threatening