BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 13948158 · Received March 30, 2022

    Report

    Report Number
    2016493-2022-122123
    Event Type
    Malfunction
    Date Received
    March 30, 2022
    Date of Event
    November 15, 2021
    Report Date
    April 12, 2022
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE REPAIRED OR THE DEVICE/LOGS BE RECEIVED FOR EVALUATION. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. THE COMPLAINANT OR REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO THE MANUFACTURER. DEVICE WAS NOT RETURNED TO MANUFACTURING FACILITY.

    Additional Manufacturer Narrative · 0

    DISREGARD THE INITIAL REPORT WITH MFR REPORT # 2016493-2022-122123. AFTER FURTHER REVIEW, IT WAS DETERMINED THAT THIS EVENT IS NOT A REPORTABLE COMPLAINT AND THE MDR WAS SUBMITTED IN ERROR.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE BD PRINCIPAL PHARMACY CONSULTANT AN ISSUE WITH THE GUARDRAILS DATA SET SOFTWARE USER INTERFACE (GRE) WHEREIN CONCENTRATION LIMITS ARE BEING DISPLAYED ON DRUG SUMMARY DIALOGUE ON DRUGS THAT HAS NO CUSTOM CONCENTRATION ENABLED. EXAMPLE PROVIDED: DATASET CHANGES REPORT WAS GENERATED FROM THE GRE FILE BY CONVERTING GRE FILE IN V9.17 TO V12.1.2. AN INCOMPLETE DATASET ENTRIES LIST HAD DILTIAZEM LISTED UNDER ADULT PROFILE. THE PHARMACY CONSULTANT THEN WENT INTO THE GRE FILE TO THE ADULT PROFILE, WENT TO THE CONTINUOUS LIBRARY, SELECTED DILTIAZEM BUT NOTICED THERE WAS NO CUSTOM CONCENTRATION ENABLED FOR DILTIAZEM YET THERE WERE CONCENTRATION LIMITS IN PLACE FROM THE INITIAL VIEW. UPON DOUBLE CLICKING ON DILTIAZEM TO GO INTO THE EDIT SETUP GROUP VIEW, THERE WAS NOT A CUSTOM CONCENTRATION ENABLED NOR WERE THERE CONCENTRATION LIMITS IN PLACE. THIS IS INCONSISTENT WITH WHAT WOULD BE EXPECTED TO SEE BASED ON THE REPORT AND GIVEN THAT NO CUSTOM CONCENTRATION WAS ENABLED FOR THIS DRUG. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT IMPACT BUT WAS NOTED THAT THE ISSUE COULD BE VERY CONFUSING FOR SOMEONE USING THE REPORTS WITH THE SOFTWARE. TO REPLICATE: PREREQUISITES: OPEN GRE V9.33.1 , CREATE NEW DATA SET , ADD NEW SETUP GROUP ¿DRUG A¿ TO PROFILE IN CONTINUOUS/BOLUS LIBRARY , ADD FULL CONCENTRATION 100 MG/100 ML , ADD UNITS ONLY CONCENTRATION ¿ MG/-- ML , SELECT BOTH CONCENTRATIONS FOR SETUP , ADD REQUIRED LIMITS INCLUDING SOFT MIN AND MAX CONCENTRATION LIMITS , GO TO MASTER LISTS > DRUGS > DRUG A , DELETE ¿ MG/--ML CONCENTRATION FROM MASTER LIST AND ACKNOWLEDGE CONFIRMATION , SAVE AND CLOSE , OPEN DATA SET IN V12.1.2 GRE , NAVIGATE TO ¿DRUG A¿ IN PROFILE. EXPECTED: DRUG A ONLY HAS 100 MG/100 ML SELECTED WITHOUT CONCENTRATION LIMITS OR INVALID DATA SET ERROR ICON (RIGHT LOWER CORNER). DRUG A NOT LISTED IN TOOLS>ERROR SUMMARY OR DATA SET CHANGES REPORT (MS WORD). ACTUAL: DRUG A ONLY HAS 100 MG/100 ML SELECTED. CONCENTRATION LIMITS ARE PRESENT DRUG SUMMARY DIALOGUE. DATA SET IS INVALID AS INDICATED BY ERROR ICON IN RIGHT LOWER CORNER. DRUG A LISTED IN TOOLS>ERROR SUMMARY AND DATA SET CHANGES REPORT (MS WORD). USER MUST ACCESS DRUG A ADD/EDIT DIALOGUE, CONCENTRATION LIMITS NOW CLEAR AND ACCEPTED CLICKING ¿ACCEPT¿ OR ¿OK¿. IMPACT: THIS IS CONFUSING FOR CUSTOMER BECAUSE ERROR NOTIFICATION POPULATES ERROR REPORTS AND SETUP DISPLAYS VALUES WHEN THERE SHOULD BE NONE. DATA SET IS RENDERED INVALID UNTIL SETUPS ARE FIXED. REQUIRES EXTRA WORK FOR THE CUSTOMER TO CLICK ADD/EDIT AND OK OR APPLY FOR EACH AFFECTED SETUP.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE BD PRINCIPAL PHARMACY CONSULTANT AN ISSUE WITH THE GUARDRAILS DATA SET SOFTWARE USER INTERFACE (GRE) WHEREIN CONCENTRATION LIMITS ARE BEING DISPLAYED ON DRUG SUMMARY DIALOGUE ON DRUGS THAT HAS NO CUSTOM CONCENTRATION ENABLED. EXAMPLE PROVIDED: DATASET CHANGES REPORT WAS GENERATED FROM THE GRE FILE BY CONVERTING GRE FILE IN V9.17 TO V12.1.2. AN INCOMPLETE DATASET ENTRIES LIST HAD DILTIAZEM LISTED UNDER ADULT PROFILE. THE PHARMACY CONSULTANT THEN WENT INTO THE GRE FILE TO THE ADULT PROFILE, WENT TO THE CONTINUOUS LIBRARY, SELECTED DILTIAZEM BUT NOTICED THERE WAS NO CUSTOM CONCENTRATION ENABLED FOR DILTIAZEM YET THERE WERE CONCENTRATION LIMITS IN PLACE FROM THE INITIAL VIEW. UPON DOUBLE CLICKING ON DILTIAZEM TO GO INTO THE EDIT SETUP GROUP VIEW, THERE WAS NOT A CUSTOM CONCENTRATION ENABLED NOR WERE THERE CONCENTRATION LIMITS IN PLACE. THIS IS INCONSISTENT WITH WHAT WOULD BE EXPECTED TO SEE BASED ON THE REPORT AND GIVEN THAT NO CUSTOM CONCENTRATION WAS ENABLED FOR THIS DRUG. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT IMPACT BUT WAS NOTED THAT THE ISSUE COULD BE VERY CONFUSING FOR SOMEONE USING THE REPORTS WITH THE SOFTWARE. TO REPLICATE: PREREQUISITES: 1.) OPEN GRE V9.33.1 2.) CREATE NEW DATA SET 3.) ADD NEW SETUP GROUP ¿DRUG A¿ TO PROFILE IN CONTINUOUS/BOLUS LIBRARY 4.) ADD FULL CONCENTRATION 100 MG/100 ML 5.) ADD UNITS ONLY CONCENTRATION ¿ MG/-- ML 6.) SELECT BOTH CONCENTRATIONS FOR SETUP 7.) ADD REQUIRED LIMITS INCLUDING SOFT MIN AND MAX CONCENTRATION LIMITS 8.) GO TO MASTER LISTS > DRUGS > DRUG A 9.) DELETE ¿ MG/--ML CONCENTRATION FROM MASTER LIST AND ACKNOWLEDGE CONFIRMATION 10.) SAVE AND CLOSE 11.) OPEN DATA SET IN V12.1.2 GRE 12.) NAVIGATE TO ¿DRUG A¿ IN PROFILE EXPECTED: 1.) DRUG A ONLY HAS 100 MG/100 ML SELECTED WITHOUT CONCENTRATION LIMITS OR INVALID DATA SET ERROR ICON (RIGHT LOWER CORNER). 2.) DRUG A NOT LISTED IN TOOLS>ERROR SUMMARY OR DATA SET CHANGES REPORT (MS WORD). ACTUAL: 1.) DRUG A ONLY HAS 100 MG/100 ML SELECTED. 2.) CONCENTRATION LIMITS ARE PRESENT DRUG SUMMARY DIALOGUE. 3.) DATA SET IS INVALID AS INDICATED BY ERROR ICON IN RIGHT LOWER CORNER. 4.) DRUG A LISTED IN TOOLS>ERROR SUMMARY AND DATA SET CHANGES REPORT (MS WORD). 5.) USER MUST ACCESS DRUG A ADD/EDIT DIALOGUE, CONCENTRATION LIMITS NOW CLEAR AND ACCEPTED CLICKING ¿ACCEPT¿ OR ¿OK¿. IMPACT: 1.) THIS IS CONFUSING FOR CUSTOMER BECAUSE ERROR NOTIFICATION POPULATES ERROR REPORTS AND SETUP DISPLAYS VALUES WHEN THERE SHOULD BE NONE. 2.) DATA SET IS RENDERED INVALID UNTIL SETUPS ARE FIXED. 3.) REQUIRES EXTRA WORK FOR THE CUSTOMER TO CLICK ADD/EDIT AND OK OR APPLY FOR EACH AFFECTED SETUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2901968 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown