BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS 8100 INFUSION PUMP

    MDR report key: 9528235 · Received December 27, 2019

    Report

    Report Number
    3007409280-2019-00130
    Event Type
    Malfunction
    Date Received
    December 27, 2019
    Date of Event
    March 30, 2018
    Report Date
    August 21, 2018
    Manufacturer
    ALARIS MEDICAL SYSTEMS, INC.
    Product Code
    FRN
    PMA / PMN Number
    K030459
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED TO THE OEM BEFORE IT WAS RETURNED TO AVANTE HEALTH SOLUTIONS. THE OEM REPORTED THAT THE PCU AND ASSOCIATED LOGS WERE NOT PROVIDED TO ENABLE REVIEW OF THE DETAILS DURING THE PROGRAMMING OF THE ALLEGED EVENT. REVIEW OF THE DEVICE LOGS DETERMINED THE SOURCE DEVICE WAS ATTACHED TO PCU S/N (B)(4) ON (B)(6) 2018 AT 5:13:15 PM. THE REPORTED OVER INFUSION WAS SUSPECTED TO HAVE OCCURRED ON MARCH 30, 2018 BETWEEN 10:14:50 AM AND 1:18:46 PM. THE FOLLOWING WAS COLLECTED TO SHOW THE PROGRAMMING OF THE SOURCE DEVICE ON THE REPORTED DAY OF THE EVENT. THE LOG TABLE BEGAN AT THE START OF THE PROGRAMMING OF THE SOURCE DEVICE AS FOLLOWS: DATE/TIME: (B)(6) 2018 10:14:50 AM: PROGRAMMED PRIMARY INFUSION: RATE: 20ML/H VTBI: 500ML INFUSION STARTED; 12:13:55 PM: PROGRAMMED SECONDARY INFUSION: RATE: 50ML/H VTBI: 50ML SECONDARY INFUSION STARTED PRIMARY INFUSION APPROXIMATE TOT. VOL. INFUSED = 40ML; 1:13:56 PM: -SECONDARY INFUSION COMPLETED SECONDARY INFUSION TOT. VOL. INFUSED = 50ML -PRIMARY INFUSION STARTS; 1:18:02 PM: PUMP ALARMS FOR AIR IN LINE; 1:18:05 PM: PUMP RESTARTED; 1:18:08 PM: PUMP PAUSED; 1:18:46 PM: PUMP CHANNELED OFF APPROXIMATE TOT. PRIMARY VOL. INFUSED = 41.33ML APPROXIMATE TOT. SECONDARY VOL. INFUSED = 50ML. EXTERNAL INSPECTION IDENTIFIED THAT THE SOURCE PUMP MODULE WAS RECEIVED WITH A NON OEM INSTRUMENT SEAL. DOOR HINGES WERE INTACT AND FUNCTIONAL. PLATEN, POSTS/HINGE, PINS/SPRINGS BUTTONS WERE ALL INTACT AND NOT INTERFERING WITH DOOR OPERATION. DOOR LATCH/SEAR AND PIVOT LATCH SCREW WAS INSTALLED AND NOT INTERFERING WITH DOOR OPERATION. IUI CONNECTORS APPEARED IN FAIR CONDITION. THE BOTTOM LEFT AREA OF THE MEMBRANE FRAME SHOWED SIGNS OF YELLOW DRIED FLUID INGRESS. THE LOWER LEFT AREA OF THE MEMBRANE FRAME/ HINGE WAS OBSERVED UNEVEN WITH ADJACENT BEZEL CAVITY. INSPECTED COMPONENTS APPEAR OEM MANUFACTURED PARTS. NO OTHER OBVIOUS ISSUES OR ANOMALIES WERE NOTED. INTERNAL INSPECTION IDENTIFIED THAT THE UNIT HAD A NON OEM REAR CASE. A SMALL PLASTIC FRAGMENT WAS NOTED UNDERNEATH THE MEMBRANE FRAME ON THE LOWER LEFT AREA. THE DETECTION SEAL LOCATED ON THE MECHANISM SCREW/S WAS NOT PRESENT, MOST LIKELY DUE TO THE AGE OF THE UNIT (NOV 2007). THE OCCLUDER SPRING (P4) WAS OBSERVED BENT UPON REMOVAL OF THE MECHANISM FRAME. BOTH OCCLUDERS AND PUMPING FINGERS WERE NOTED WITH CONTAMINATION. DEVICE TESTING FOUND THAT THE PERCENTAGE OF ERROR WAS 42.6667% WHICH WAS NOT WITHIN THE ACCEPTABLE ERROR OF +/-3.400%. THE CONTAMINATION IDENTIFIED ON THE OCCLUDER AND PUMPING FINGERS WAS CLEANED OFF AND THE PUMP MODULE COMPONENTS WERE REPLACED TO RE-TEST FOR RATE ACCURACY THROUGH ASM. RATE ACCURACY SHOWED THE PUMP MODULE PASSING, WITH PERCENTAGE OF ERROR OF -0.0833%. DURING THE PRIMING STEP OF THE TEST, THE ADMINISTRATION SET DID NOT EXHIBIT UNCONTROLLED FLUID FLOW AS PREVIOUSLY IDENTIFIED. THE REPORT OF AN OVER INFUSION WITH FREE FLOW WAS REPLICATED DURING LABORATORY TESTING. THE PROXIMATE CAUSE WAS DUE TO A BENT OCCLUDER SPRING. IT SUSPECTED THAT THE DRIED FLUID RESIDUE IN THE OCCLUDERS AND PUMPING FINGERS WERE A CONTRIBUTING FACTOR TO THE REPORTED EVENT. THE COMPLAINT DEVICE WAS THEN RETURNED TO AVANTE HEALTH SOLUTION; HOWEVER, AS THE OEM HAD REPAIRED THE DEVICE THERE WAS NO PROBLEM FOUND. THIS TYPE OF EVENT WILL CONTINUE TO BE MONITORED. IT SHOULD BE NOTED THAT THIS IS BEING FILED BASED ON RETROSPECTIVE REVIEW.

    Description of Event or Problem · 1

    REPORTEDLY, POST REPAIR, A PATIENT WAS TO RECEIVE SALINE AT 20 ML/HOUR WITH A VTBI OF 490 ML AS A PRIMARY INFUSION, AND A 50 ML INFUSION OF ROCEPHIN. ABOUT FOUR HOURS AFTER STARTING THE INFUSION, THE SALINE IV BAG WAS EMPTY AND THE DEVICE WAS ALARMING AIR IN LINE. THE PUMP SAID THAT ONLY 141 ML TOTAL VOLUME WAS INFUSED. THE CUSTOMER TESTED THE DEVICE TO DELIVER 50 ML AND FOUND IT DELIVERED 66 ML, AND THAT THE UNIT ALLOWED FLUID TO FREE FLOW WHEN TURNED OFF. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1320475 ALARIS 8100 INFUSION PUMP MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS FRN ALARIS MEDICAL SYSTEMS, INC. FIAL2100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other