BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURLIN 6000 INFUSION PUMP

    MDR report key: 1894030 · Received November 2, 2010

    Report

    Report Number
    MW5018058
    Event Type
    Injury
    Date Received
    November 2, 2010
    Date of Event
    August 17, 2010
    Report Date
    November 2, 2010
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    ROUTINE DAILY TPN INFUSION VIA CURLIN 6000 PUMPS BY PT AND CAREGIVER MOTHER VERY FAMILIAR WITH USING EQUIPMENT. CALL REC'D DURING THE NIGHT WITH MOM REPORTING THAT THE CURLIN PUMP WAS COMPLETELY BLANK AND NOT WORKING. SHE CHANGED THE BATTERIES AND NOTHING STILL. SHE WAS RUNNING A 2ND PUMP WITH A HYDRATION BOLUS. RPH ARRANGED FOR DELIVERY OF 2 NEW PUMPS ASAP...FOR THE TPN AND ANOTHER SPARE TO HAVE ON HAND. PT WENT TO THE HOSPITAL LATER THAT DAY TO BE CHECKED OUT AND CLINIC NOTIFIED OF DELAYED/MISSED INFUSION TIME. POTENTIAL PROBLEM PUMP NUMBERS: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURLIN 6000 INFUSION PUMP CURLIN PUMP FRN

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Disability