BEUDAMED
    FDA Adverse Event Summary report: N

    CURLIN INFUSION 4000CMS IV PUMP

    MDR report key: 2010377 · Received February 21, 2011

    Report

    Report Number
    1722139-2011-00020
    Date Received
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: DEVICE WAS TESTED AND DELIVERED +5.5% OF INTENDED DOSE. THIS IS SLIGHTLY OUT OF THE +/-5% SPECIFICATION FOR ACCURACY. THE PATIENT CLAIMED UNDER DELIVERY. A REVIEW OF THE PUMP HISTORY LOG SHOWS ON (B)(6), A SUCCESSFUL INFUSION OF 3000ML AT 200ML/HR WAS DELIVERED. ON (B)(6), A REPEAT RX WAS ENTERED AT 18:29 HOURS. IT WAS PRIMED THEN TURNED OFF AND BACK ON AT 18:33HRS. REPEAT RX WAS ENTERED AGAIN AT 18:34HRS. THE DEVICE WAS PRIMED FOR 49.3ML FROM 18:34 TO 18:44HRS AND TURNED OFF AND BACK ON AT 18:46HRS. AGAIN AT 18:46 REPEAT RX WAS ENTERED AND THERAPY STARTED. FROM 18:46 TO 18:51 THE PUMP DELIVERED .5ML, HAD A DOOR OPEN ALARM AND WAS TURNED OFF. IT WAS TURNED ON AT 19:11 ON (B)(6). FROM 19:11 TO 19:36HRS THE DEVICE HAD 5 DOWN OCCLUSION ALARMS, 2 DOOR OPEN ALARMS AND 2 UNATTENDED ALARMS AND DELIVERED 0.7ML AND WAS PRIMED FOR 24.3ML. THE DEVICE WAS TURNED ON AGAIN (B)(6) AT 13:10 WHERE A NEW PROGRAM WAS MADE FOR 200ML DOSE AT 400ML/HR RATE. THIS INFUSION WAS COMPLETED AS PROGRAMMED. REPEAT RX WAS ENTERED AT 13:54 AND SUCCESSFULLY COMPLETED AT 14:24 AND TURNED OFF. ON (B)(6), IT WAS TURNED ON/OFF. (B)(6) THE REPEAT RX WAS ENTERED AND REVIEWED (3000ML AT 187.5ML/HR. IT APPEARS THE PATIENT HAD DIFFICULTY COMPLETING THE 3000ML INFUSION ON (B)(6) WITH DOWN OCCLUSION ALARMS. IT IS DIFFICULT TO SEE WHAT CAUSED THE UNDER DELIVERY AS CLAIMED BY THE PATIENT.

    Description of Event or Problem · 1

    COMPLAINT DESCRIPTION: "UNDER INFUSING." PATIENT WAS ON TPN INFUSION. THERE WAS 300ML LEFT AFTER "DOSE DONE." PATIENT SWITCHED TO A DIFFERENT PUMP AND GAVE HIMSELF THE REMAINDER OF THE DOSE. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURLIN INFUSION 4000CMS IV PUMP FRN MOOG MEDICAL DEVICES GROUP

    Patients

    Seq Age Sex Outcome Treatment
    1