BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM V/NV 20D 1CV 2SS DEHP FREE

    MDR report key: 10299870 · Received July 20, 2020

    Report

    Report Number
    9616066-2020-02270
    Event Type
    Malfunction
    Date Received
    July 20, 2020
    Date of Event
    June 26, 2020
    Report Date
    June 29, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.
    Product Code
    FPA
    UDI-DI
    07613203021012
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL YES, D.10 RETURNED TO MANUFACTURER ON: 07/06/2020 INVESTIGATION CONCLUSION THE CUSTOMER REPORTED ¿A BALLOON (BULGE) IN THE IV TUBING". RECEIVED FROM THE CUSTOMER ONE USED PRIMARY SET MODEL 2420-0007 LOT 20045133. AN ORANGE ALCOHOL DISINFECTING CAP WAS ATTACHED TO THE SET¿S DISTAL SMARTSITE. THE SET WAS VISUALLY INSPECTED FOR KINKS, INCOMPLETE BONDING ENGAGEMENTS, HOLES/ TEARS IN THE TUBING OR DAMAGES TO THE COMPONENTS. IT WAS OBSERVED THAT THE SILICONE SEGMENT TUBING (P/N 12088541) HAD A BULGE, DISCOLORATION, AND WAS WEAKENED JUST BELOW THE UPPER FITMENT (P/N TC10008721). CLEAR LIQUID WAS OBSERVED INSIDE THE SET¿S TUBING AND DRIP CHAMBER. NO OTHER ABNORMALITIES WERE OBSERVED ON THE SET DURING VISUAL INSPECTION. FUNCTIONAL TESTING OF PREVIOUS COMPLAINTS WITH THE FAILURE MODE OF ¿BALLOON/BULGE IN SILICONE TUBING SEGMENT¿ WAS PERFORMED BY PLACING THE INFUSION SET IN AN ALARIS PUMP MODULE AND CLOSING THE DOOR, PROGRAMMING/RUNNING THE INFUSION, PAUSING THE INFUSION, AND THEN INJECTING AN IV PUSH FLUID BOLUS THROUGH A DISTAL Y-SITE OF THE INFUSION SET. TESTING INCLUDED INJECTING AN IV PUSH BOLUS AFTER CLAMPING THE TUBING (BELOW THE PUMP SEGMENT BUT ABOVE THE IV PUSH SITE PER THE DFU) AND INJECTING THE IV PUSH BOLUS WITHOUT CLAMPING THE TUBING. BALLOONING WAS NOT REPLICATED IN ANY CLAMPED TESTING BUT HAS BEEN REPLICATED IN UNCLAMPED TESTING WHEN THE TUBING HAD BEEN VISUALLY OBSERVED TO BE COMPROMISED (FROM PREVIOUS BALLOONING). DUE TO THE HIGH NUMBER OF PREVIOUSLY INVESTIGATED COMPLAINTS FOR THIS SAME FAILURE MODE EXHIBITING THE SAME VISUAL OBSERVATIONS AND FUNCTIONAL TESTING RESULTS OF BALLOONING CAUSED BY EXCESS PRESSURE WITHIN THE SILICONE TUBING SEGMENT WHEN THE TUBING IS NOT CLAMPED PER THE DFU INSTRUCTIONS, FURTHER FUNCTIONAL TESTING OF EVENTS REPORTED FOR BALLOON/BULGE IN THE SILICONE TUBING SEGMENT IS NOT REQUIRED. THIS RATIONALE IS SUPPORTED BY INSTRUCTION 7.2.2 OF 1503-001-000-SWI-MMS (V. 02) CAD COMPLAINT FAILURE INVESTIGATION (DIR #10000360030_02) THAT STATES THAT THE COMPLAINT FAILURE INVESTIGATION IS NOT REQUIRED IF THE INVESTIGATION ON THE REPORTED EVENT HAS BEEN PREVIOUSLY PERFORMED AND IS SUPPORTED BY THE TECHNICAL CUSTOMER ADVOCACY MANAGER. FURTHER VISUAL INSPECTION OF THE SILICONE TUBING CONFIRMED THAT THE TUBING'S CONCENTRICITY WAS WITHIN SPECIFICATION. EQUIPMENT USED (VISUAL INSPECTION PERFORMED ON 10-SEP-20) - OPTICAL RAM-CNC, EQ08204, CALIBRATION DUE DATE: 05-FEB-21 THE DEVICE HISTORY RECORD FOR PRIMARY SET MODEL 2420-0007 LOT 20045133 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) IN 1 LOT WERE BUILT ON 05 APRIL 2020. THERE WERE NO RELATED QN¿S (QUALITY NOTIFICATIONS) ISSUED DURING THE PRODUCTION BUILD OF THIS SET FOR THE FAILURE MODE REPORTED FOR THE GIVEN TIME FRAME. THE CUSTOMER¿S REPORT OF A BALLOON (BULGE) IN THE IV TUBING WAS CONFIRMED ON PRIMARY SET MODEL 2420-0007. PREVIOUSLY INVESTIGATED COMPLAINTS FOR THIS SAME FAILURE MODE DETERMINED THAT THE BALLOONING IS CAUSED BY EXCESS PRESSURE WITHIN THE SILICONE TUBING SEGMENT. THE ROOT CAUSE FOR THE SOURCE OF THE EXCESSIVE PRESSURE IS UNKNOWN. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF GEM V/NV 20D 1CV 2SS DEHP FREE EXPERIENCED TUBING EXPANSION/BULGING AND WERE CLOGGED/BLOCKED/OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BASED ON A REVIEW OF OUR FAQ¿S IT SEEMS THIS SOMETIMES OCCURS WITH AN IV PUSH CAUSING EXCESSIVE PRESSURES AND BALLOON THE SILICONE TUBING IN THE PUMP PORTION OF TUBING. THE RECOMMENDATION IS TO CLAMP OFF THE TUBING ABOVE THE PUSH SITE, BELOW THE PUMP, TO PREVENT EXCESSIVE PRESSURE FROM REACHING THE PUMPING CHAMBER ¿ DO YOU KNOW WHEN THE INCIDENT HAPPEN IF FEASIBLE PLEASE PROVIDE DATE (S). (B)(6)/20 ¿ DO YOU HAVE ITEM NAME AND LOT NUMBER? REF#(B)(4), LOT# (10)20045133

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF GEM V/NV 20D 1CV 2SS DEHP FREE EXPERIENCED TUBING EXPANSION/BULGING AND WERE CLOGGED/BLOCKED/OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BASED ON A REVIEW OF OUR FAQ¿S IT SEEMS THIS SOMETIMES OCCURS WITH AN IV PUSH CAUSING EXCESSIVE PRESSURES AND BALLOON THE SILICONE TUBING IN THE PUMP PORTION OF TUBING. THE RECOMMENDATION IS TO CLAMP OFF THE TUBING ABOVE THE PUSH SITE, BELOW THE PUMP, TO PREVENT EXCESSIVE PRESSURE FROM REACHING THE PUMPING CHAMBER DO YOU KNOW WHEN THE INCIDENT HAPPEN IF FEASIBLE PLEASE PROVIDE DATE (S) (B)(6) 2020. DO YOU HAVE ITEM NAME AND LOT NUMBER? REF#2420-0007, LOT# (10)20045133.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763823 GEM V/NV 20D 1CV 2SS DEHP FREE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C. 20045133 07613203021012

    Patients

    Seq Age Sex Outcome Treatment
    1 Other