BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTEC INC.

    MDR report key: 414301 · Received August 29, 2002

    Report

    Report Number
    MW1026031
    Event Type
    Injury
    Date Received
    August 29, 2002
    Date of Event
    August 28, 2002
    Report Date
    August 29, 2002
    Manufacturer
    DELTEC INC.
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    OVERINFUSION OF MEDICATION TO PT DUE TO FAULTY DELTEC INC TUBING SET CC4203 LOT# APR02T18 OR CC4203 LOT# JAN02T27. FAULT IN TUBING SET PREVENTS THE 3M INFUSION PUMP MODEL 3000 FROM CLOSING A PINCH VALVE COMPLETELY. WHEN THIS HAPPENS GRAVITY CAUSES FREE-FLOW OF SOLUTION TO THE PT. IN THIS CASE THE RATE OF INFUSION WAS SET FOR 20ML/HR BUT THE 100ML BAG OF SOLUTION WAS COMPLETELY DRAINED IN 30 MINS. THIS IS THE THIRD CASE SINCE 1/02 IN WHICH THE DELTEC TUBING SET WAS PROVEN TO BE THE CAUSE OF THE PT OVERDOSE. DELTEC HAS BEEN CONTACTED EACH TIME AND THEY HAVE AGREED IN WRITTEN FORM THAT THE INCIDENT OF 1/02 WAS CAUSED BY THE DEFECTIVE TUBING SET. THE SECOND INCIDENT HAPPENED 7/02. AGAIN DELTEC WAS NOTIFIED AND A FORM 3500 WAS FILLED OUT AND MAILED TO MEDWATCH. DELTEC REQUESTED THE FAULTY TUBING SET AND IT WAS SENT TO THEM ON 8/02. RPTR HAS NOT HAD A RESPONSE FROM DELTEC SINCE THEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTEC INC. TUBING SET CC4203 LOT# APR02T18 OR JAN02T27 FPA DELTEC INC. * APR 02T18 OR JAN 02T27

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention