BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURLIN 4000

    MDR report key: 787915 · Received November 29, 2006

    Report

    Report Number
    MW1041211
    Event Type
    Injury
    Date Received
    November 29, 2006
    Date of Event
    November 17, 2006
    Report Date
    November 28, 2006
    Manufacturer
    CURLIN MEDICAL LLC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS RN INSTRUCTED PT ON USE OF CURLIN PUMP. RN DEMONSTRATED STARTING PUMP WHILE PT FOLLOWED WRITTEN INSTRUCTIONS. PT THEN STARTED AND STOPPED AND TURNED PUMP OFF 2-3 TIMES WHILE RN READ WRITTEN INSTRUCTIONS TO PT. OBSERVED PT PRIME TUBING AND LOAD TUBING INTO PUMP AFTER DEMONSTRATING PROCEDURE TO PT. RN THEN INSTRUCTED PT TO START PUMP. PT STARTED PUSHING BUTTONS ON PUMP IN AUTOMATIC MOTION AS IF SHE HAD HER BAXTER 6060 PUMP. NOTICED PUMP NOT STARTING-LOOKED AT SCREEN-PARAMETERS WERE AT "0" AS IF READY TO PROGRAM. RN TURNED PUMP OFF AND RESTARTED-PUMP PARAMETERS WERE ALL AT "0." RN CALLED BRANCH PHARMACIST TO REPORT PROBLEM. PHARMACIST HAD RN CHECK FOLLOWING: PUMP WAS IN LOCK LEVEL 2 AND IN TPN ONLY MODE. PHARMACIST RECOMMENDED RN CALL CURLIN CLINICAL HELP LINE. CURLIN CLINICAL RN ASSISTED WITH REPROGRAMMING PUMP AND PLACING IN LOCK MODE. RN THEN HAD PT START, STOP AND TURN PUMP OFF 3 TIMES. NO PROBLEMS. PUMP APPEARED TO BE FUNCTIONING PROPERLY. PUMPS TO BE SENT TO CURLIN FROM BIOMED. EVAL SOFTWARE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURLIN 4000 INFUSION PUMP FRN CURLIN MEDICAL LLC 4000 CMS *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention