BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN 4000 PLUS

    MDR report key: 2994278 · Received March 1, 2013

    Report

    Report Number
    MW5029237
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    November 28, 2012
    Report Date
    March 1, 2013
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    FUNCTIONAL TESTING OF MOOG MEDICAL CURLING 4000 PLUS INFUSION PUMP REVEALED THAT THE PUMPS WERE DELIVERING LOWER THAN EXPECTED VOLUMES. THIS PROBLEM WAS FIRST NOTICED ON 3 PUMPS, AND SUBSEQUENT TESTING REVEALED THAT THE UNDERINFUSING PROBLEM EXISTED ACROSS THE HOSPITAL¿S FLEET OF 16 PUMPS. USING MOOG MICRO BORE TUBING- CATALOG NUMBER 340-4166-, PUMPS CONSISTENTLY DELIVER 7%-9% LOWER VOLUME THAN EXPECTED. PUMPS DELIVER ACCURATE VOLUMES WHEN TESTED WITH THE CALIBRATED TUBING TEST SET. MOOG HAS BEEN UNRESPONSIVE IN WORKING WITH BIOMED ON THIS PROBLEM. THE PROBLEM WAS FIRST NOTICED ON (B)(6) 2012. AT THAT TIME, 2 PUMPS WERE BEING TESTED IN BIOMED FOR ACCURACY. AN ELECTRONIC SCALE ¿ACCULAB VIC-212- WAS USED TO MEASURE THE VOLUME INFUSED. BOTH PUMPS DELIVERING LOW ALERTED THE BIOMEDICAL TECH TO A POTENTIAL PROBLEM. ON (B)(6), THE HOSPITAL¿S FLEET OF 16 PUMPS TESTED FOR VOLUME ACCURACY AND ALL DELIVERED CONSISTENTLY LOW. IN EARLY (B)(6), AFTER SPEAKING WITH MOOG, MORE EXTENSIVE TESTING WAS DONE BY BIOMED. PUMP SERIAL NUMBER (B)(4) WAS CALIBRATED PER THE TECHNICAL/SERVICE MANUAL- CHAPTER 7, PAGE 76. AFTER CALIBRATION WAS COMPLETE, THE MFR¿S RECOMMENDED VOLUMETRIC TESTS WERE DONE. THE FIRST TEST WAS FOR FUNCTIONAL TESTING- SERVICE MANUAL, CHAPTER 8, PAGE 82-, AND ALSO THE TEST FOR CHECKING PUMPS BETWEEN PATIENT SERVICE MANUAL, CHAPT 4, PAGE 48. VARIOUS LOTS OF THE ADMINISTRATION SETS, CATALOG NUMBER: 340-4166, WERE TESTED WITH THE PUMP. LOT NUMBERS: CF1217407, CF1217802, AND CF1217406 WERE TESTED AND ALL DELIVERED CONSISTENTLY LOW. AN EPIDURAL SET DELIVERED THE CORRECT VOLUME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89081 CURLIN 4000 PLUS INFUSION PUMP FRN MOOG MEDICAL DEVICES GROUP CF1217407
    89082 MICROBORE TUBING ADMINISTRATION SET MICROBORE TUBING FPA MOOG MEDICAL DEVICES GROUP CF1217407
    89083 MICROBORE TUBING ADMINISTRATION SET MICROBORE TUBING FPA MOOG MEDICAL DEVICES GROUP CF1217802
    89352 MICROBORE TUBING ADMINISTRATION SET MICROBORE TUBING FPA MOOG MEDICAL DEVICES GROUP CF1217406

    Patients

    Seq Age Sex Outcome Treatment
    1