BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM NV/V NTG 0.2MF 1YS 20D 20P

    MDR report key: 10597703 · Received September 28, 2020

    Report

    Report Number
    9616066-2020-02884
    Event Type
    Malfunction
    Date Received
    September 28, 2020
    Date of Event
    August 26, 2020
    Report Date
    August 27, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FPA
    PMA / PMN Number
    K931173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ZA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: B.5. DESCRIBE EVENT OR PROBLEM: THE EVENT DESCRIPTION HAS BEEN UPDATED WITH THE CORRECT NUMBER OF OCCURRENCES, WHICH IS 1.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT GEM NV/V NTG 0.2MF 1YS 20D 20P HAD FLOW ISSUES ON 1 OCCASION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE REPORTED FEEDBACK SUGGESTS THAT THERE IS A PROBLEM WITH THE SET. PRODUCT REFERENCE NUMBER: PRODUCT CODE 2264-0006 - LOW SORB SET WITH 0,2 MICRON FILTER PROBLEM REPORTED: USE OF TAXOL INFUSION SETS NOT RUNNING EFFECTIVELY/SMOOTHLY VIA ALARIS SYSTEM INFUSION PUMP; CUSTOMER REPORTS ERRROR MESSAGE ' NEEDS LINE CHECK'; CUSTOMER HAS TO REMOVE SET CONTINUOUSLY AND REINSERT INTO ALARIS INFUSION SYSTEM PUMP SEVERAL TIMES BEFORE PROBLEMS RESOLVED; TAXOL INFUSION SET HOWEVER INFUSES WITHOUT A PROBLEM WHEN ADMINISTERED BY GRAVITY INFUSION. ALARIS SYSTEM GENERAL SETS FOR CRYSTALLOID/CLEAR FLUID ADMINISTRATION DO NOT GIVE A PROBLEM (ONLY THE TAXOL ADMINISTRATION SETS ARE PROBLEMATIC.).

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: FOUR 2264-0006 SAMPLES WERE RECEIVED FOR INVESTIGATION. THREE SAMPLES WERE RECEIVED IN SEALED PACKAGING AND ONE WAS RECEIVED IN OPENED PACKAGING WITH RESIDUAL FLUID IN THE LINE. NOTE THE LOT NUMBER WAS NOT INDICATED IN THE PACKAGING. A VISUAL INSPECTION OF THE SAMPLES DID NOT IDENTIFY SIGNS OF DAMAGE OR MANUFACTURING ISSUES WHICH COULD HAVE CONTRIBUTED TO THE CUSTOMER'S EXPERIENCE. THE SAMPLE RECEIVED IN OPENED PACKAGING WAS PRIMED BY GRAVITY AND CONNECTED TO AN ALARIS PC PUMP FROM RETAINED BD STOCK, FUNCTIONAL TESTING WAS PERFORMED BY RUNNING AN INFUSION FOR 10 MINUTES AT 25ML/HR; NO PUMP INTERACTION ISSUES OR ERROR MESSAGES WERE IDENTIFIED DURING TESTING. THE SAMPLES IN SEALED WERE TESTED IN PTL. NO FAULT OR ALARM WAS PROMPTED FROM THE IV PUMP DURING TESTING. ROOT CAUSE ANALYSIS: IN THIS INSTANCE WITHOUT THE PUMP IN USE AT THE TIME OF THE CUSTOMER'S EXPERIENCE IT IS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE. INVESTIGATION CONCLUSION: FOUR 2264-0006 SAMPLES FROM LOT 18025104 WERE RECEIVED FOR INVESTIGATION. THREE SAMPLES WERE RECEIVED IN SEALED PACKAGING AND ONE WAS RECEIVED IN OPENED PACKAGING WITH RESIDUAL FLUID IN THE LINE (APPENDIX 1). THE INFUSION PUMP IN USE AT THE TIME OF THE CUSTOMER'S EXPERIENCE WAS NOT RETURNED TO ASSIST THE INVESTIGATION. A VISUAL INSPECTION OF THE SAMPLES DID NOT IDENTIFY SIGNS OF DAMAGE OR MANUFACTURING DEFECTS WHICH COULD HAVE CONTRIBUTED TO THE CUSTOMER'S EXPERIENCE. THE SAMPLES WERE PRIMED BY GRAVITY AND CONNECTED TO AN ALARIS SYSTEM PUMP FROM RETAINED BD STOCK, FUNCTIONAL TESTING WAS PERFORMED BY RUNNING A SHORT INFUSION; NO PUMP INTERACTION ISSUES OR ERROR MESSAGES WERE IDENTIFIED DURING TESTING. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 18025104 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS, WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. PLEASE NOTE THE 'CHECK LINE' ALARM IS A FEATURE THAT MONITORS THE DOWNSTREAM PRESSURE OF THE INFUSION PUMP. AS THE PRESSURE REACHES THE ALARM LIMIT THE PUMP PAUSES THE INFUSION AND MONITORS THE PRESSURE OVER 15 SECONDS, AND IF THE PRESSURE REMAINS THE PUMP ALARMS FOR 'PATIENT-SIDE OCCLUSION' AND STOPS THE INFUSION. HOWEVER IF THE PRESSURE DECREASES TO LESS THAN 50% OF THE ALARM LEVEL DURING THE 15 SECONDS, THEN THE PUMP PERFORMS AN AUTO-RESTART AND THE INFUSION CONTINUES. IN THIS INSTANCE IT IS POSSIBLE THAT IF THE PRESSURE ALARM LEVEL OF THE PUMP WAS SET TO A LOW LEVEL, AND A VISCOUS FLUID WAS BEING INFUSED THROUGH AN INFUSION SET CONTAINING A FILTER DOWNSTREAM OF THE PUMP, IT MAY HAVE CONTRIBUTED TO THE REPORTED ALARMS. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS AN ISOLATED REPORT WITH NO OTHER SIMILAR REPORT AGAINST THE 2264-0006 SET IN THE PAST 12 MONTHS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT GEM NV/V NTG 0.2MF 1YS 20D 20P HAD FLOW ISSUES ON 4 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE REPORTED FEEDBACK SUGGESTS THAT THERE IS A PROBLEM WITH THE SET. PRODUCT REFERENCE NUMBER: PRODUCT CODE 2264-0006, LOW SORB, SET WITH 0,2 MICRON FILTER PROBLEM REPORTED: USE OF TAXOL INFUSION SETS NOT RUNNING EFFECTIVELY/SMOOTHLY VIA ALARIS SYSTEM INFUSION PUMP; CUSTOMER REPORTS ERRROR MESSAGE ' NEEDS LINE CHECK'; CUSTOMER HAS TO REMOVE SET CONTINUOUSLY AND REINSERT INTO ALARIS INFUSION SYSTEM PUMP SEVERAL TIMES BEFORE PROBLEMS RESOLVED; TAXOL INFUSION SET HOWEVER INFUSES WITHOUT A PROBLEM WHEN ADMINISTERED BY GRAVITY INFUSION. ALARIS SYSTEM GENERAL SETS FOR CRYSTALLOID/CLEAR FLUID ADMINISTRATION DO NOT GIVE A PROBLEM (ONLY THE TAXOL ADMINISTRATION SETS ARE PROBLEMATIC.).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055958 GEM NV/V NTG 0.2MF 1YS 20D 20P INTRAVASCULAR ADMINISTRATION SET FPA CAREFUSION SD 2264-0006 18025104

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 20200826.| 20200826