BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFUSE INFUSION PUMP

    MDR report key: 21765 · Received May 11, 1995

    Report

    Report Number
    MW1005903
    Event Type
    Injury
    Date Received
    May 11, 1995
    Date of Event
    April 13, 1995
    Report Date
    April 16, 1995
    Manufacturer
    BLOCK MEDICAL, INC.
    Product Code
    MEB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT RECEIVING CONTINUOUS INFUSION GYCLOSPORINE (S/P BILATERAL LUNG TRANSPLANT) VIA PUMP. PUMP DELIVERED 24 HR DOSE OF MEDICATION OVER 2 HRS. PUMP WAS PROPERLY PROGRAMMED AND PROBLEM COULD NOT BE DUPLICATED WHEN RETURNED TO RPTR'S CTR. PT HAS HX OF SEIZURES AND ASPIRATION AND WAS AT ADD'L RISK FOR BOTH, SECONDARY TO PUMP MALFUNCTION SUBSEQUENT OVERADMINISTRATION. PT ULTIMATELY EXPERIENCED NO ILL EFFECTS. PUMP AND TUBING USED WRE RETURNED TO MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIFUSE INFUSION PUMP MEB BLOCK MEDICAL, INC. RMA #7614

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Life Threatening HICKMAN CATHETER, SOLUMEDRAL IV BID, HEPARANIZED| SALINE.