BEUDAMED
    FDA Adverse Event Death Summary report: N

    CURLIN INFUSION 4000CMS IV PUMP

    MDR report key: 1600975 · Received February 11, 2010

    Report

    Report Number
    1722139-2010-00005
    Event Type
    Death
    Date Received
    February 11, 2010
    Date of Event
    January 11, 2010
    Report Date
    February 9, 2010
    Manufacturer
    MOOG MEDICAL DEVICES GROUP.
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL DEVICE WAS EVALUATED. PERFORMANCE TESTS WERE COMPLETED, INCLUDING THE STANDARD ACCURACY TESTS, PRESSURE TESTS AND THE DEVICE WAS RUN AT THE SAME PARAMETERS/SETTINGS THE CUSTOMER USED. A VISUAL INSPECTION OF THE DEVICE EXTERIOR AND INTERIOR WAS COMPLETED. EXTERIOR DAMAGE WAS NOTED ON BATTERY DOOR, FRONT BEZEL AND REAR CASE. RESULTS: FLUID INGRESS (BROWN RESIDUE) WAS DISCOVERED INTERNALLY ON THE PCB, FRONT AND BACK CASE AND VARIOUS OTHER INTERNAL COMPONENTS. DEVICE PERFORMED TO SPECIFICATIONS DURING THE PERFORMANCE TESTS CONDUCTED AT MOOG. COULD NOT DUPLICATE THE FAILURE. FLUID INGRESS LIKELY CAUSED SHORT CIRCUITS, WHICH LED TO THE PUMP COMMUNICATION SIGNALS TO BE ADVERSELY AFFECTED; I.E. SIGNALS DID NOT GET SENT OR SIGNALS WERE NOT RECEIVED CORRECTLY DUE TO THE PRESENCE OF FLUID ON THE PCB COMPONENTS. CONCLUSION: DEVICE FAILURE (FLUID INGRESS SHORTED THE PCB) CAUSED BY EXTERNAL DAMAGE AND SUBSEQUENT FLUID INGRESS DIRECTLY CAUSED PUMP TO NOT DETECT OVER DELIVERY. DEVICE EXPERIENCED 53 ALARMS (13 ERROR CODE 10, 11 ERROR CODE 15 AND 29 OCCLUSION) FROM (B) (6) BEFORE THE OVER DELIVERY OCCURRED. THE PUMP HAD OBVIOUS PROBLEMS AND THE LABELING CLEARLY STATES IF THERE IS DAMAGE, SHOWS REPEATED ERROR CODES OR INDICATES ITS NOT PERFORMING CORRECTLY TO RETURN THE PUMP TO THE HEALTH CARE PROVIDER/MANUFACTURER. THE DEVICE PASSED ALL FUNCTIONAL/PERFORMANCE CRITERIA. OVER DELIVERY COULD NOT BE DUPLICATED. THE INFORMATION IN THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE INCIDENT.

    Description of Event or Problem · 1

    AN (B) (6) YEAR OLD, TERMINALLY ILL (END STAGE CANCER), HOME HOSPICE, PATIENT, WAS ORDERED AN INFUSION OF DILAUDID WITH A CONTINUOUS BASAL RATE OF 0.5MG/HR OF 500MG IN A 0.5MG/HR AS NEEDED EVERY 15 MINUTES. WHILE THE NURSE WAS PROGRAMMING AND ATTEMPTING TO RUN THE PUMP, IT EXPERIENCED 41 ERROR CODES OR ALARMS. A REPLACEMENT PUMP WAS ATTEMPTED AND ALSO EXPERIENCED ERROR CODES. THE CAREGIVER RETURNED TO THIS PUMP ((B) (4)) AND THEN IT INFUSED FOR ABOUT 2 HOURS. AT THAT POINT THE PUMP EXPERIENCED AN UP OCCLUSION ALARM AND THE BAG WAS OBSERVED TO BE EMPTY AND THE PATIENT HAD DECEASED.

    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 88 YR Death