BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BODYGUARD

    MDR report key: 2319124 · Received October 13, 2011

    Report

    Report Number
    3006967710-2011-00001
    Event Type
    Malfunction
    Date Received
    October 13, 2011
    Report Date
    September 15, 2011
    Manufacturer
    CME AMERICA, LLC.
    Product Code
    FRN
    PMA / PMN Number
    K042696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE REPORTER, ON (B)(6) 2011 AT 11:45 AM, THE NURSE SET UP A NEW DRUG RESERVOIR WITH 45 ML OF DILAUDID. THE DRUG CONCENTRATION WAS 10 MG/ML. THE PRESCRIBED DELIVERY WAS 16 MG/HR BASAL RATE WITH A 4 MG BOLUS EVERY 10 MINS. THE PUMP WAS CHECKED AT 1:45 PM, THE SAME DAY AND THE RESIDUAL VOLUME DISPLAYED 11.3 ML, BUT WAS EXPECTED TO DISPLAY 41.8 ML (I.E., 2 HOURS AT 1.6 ML/HR). THIS INDICATED THAT SIGNIFICANT OVER-DELIVERY OCCURRED. THE INFUSION PUMP WAS RETURNED, EVALUATED, AND TESTED PER STANDARD TEST PROCEDURES BY THE MFR. PERFORMANCE TESTING OF THE PUMP DEMONSTRATED THAT IT FUNCTIONED WITHIN SPECIFICATION. REVIEW OF THE PUMP'S EVENT HISTORY INDICATED THAT THE PUMP WAS INITIALLY INCORRECTLY PROGRAMMED BY THE HEALTH CARE PROFESSIONAL IN "VOLUME MODE", CAUSING THE OVER-DELIVERY. THE PROVIDER DISCOVERED THE ERROR AT THE 1:45 PM CHECK AND CORRECTLY RE-PROGRAMMED THE PUMP IN "CONCENTRATION MODE" WHICH RESOLVED THE OVER-DELIVERY EVENT. FOLLOW-UP WITH THE INITIAL REPORTER (HEALTH CARE PROFESSIONAL) CONFIRMED THE CAUSE OF THE EVENT WAS USER ERROR. A REVIEW OF THE DEVICE OPERATOR'S MANUAL (REF 100-090XC) CONFIRMS THAT INSTRUCTIONS ARE PROVIDED FOR PROPER PROGRAMMING IN CONCENTRATION MODE. A REVIEW OF HISTORICAL RECORDS INDICATES THERE HAVE BEEN NO SIMILAR REPORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN AMBULATORY INFUSION PUMP SIGNIFICANTLY OVER-DELIVERED DURING PAIN MANAGEMENT THERAPY. THE REPORTER INDICATED THERE WAS NO PT HARM. TESTING AND EVAL OF THE RETURNED PUMP BY THE MFR DEMONSTRATED THAT THE HEALTH CARE PROFESSIONAL SET UP THE PUMP IN "VOLUME DELIVERY MODE" RATHER THAN THE "DRUG CONCENTRATION DELIVERY MODE" RESULTING IN THE OVER-DELIVERY. THE OPERATOR'S MANUAL PROVIDES INSTRUCTIONS FOR SETTING UP THE PUMP IN EITHER DELIVERY MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BODYGUARD FRN (INFUSION PUMP) FRN CME AMERICA, LLC. BG 323

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR