BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 10618381 · Received October 2, 2020

    Report

    Report Number
    2016493-2020-09553
    Event Type
    Malfunction
    Date Received
    October 2, 2020
    Report Date
    May 19, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S COMPLAINT OF THE DEVICE FAILING PATIENT SIDE OCCLUSION TESTING DURING PREVENTATIVE MAINTENANCE WAS NOT DEFINITIVELY CONFIRMED DURING TESTING. HOWEVER, THE PATIENT SIDE PRESSURE SENSOR WAS IDENTIFIED SLIGHTLY OUT OF SPECIFICATION, WHICH MAY HAVE ATTRIBUTED TO THE FAILURE TO OCCLUDE FOR PATIENT SIDE OCCLUSION. INTERNAL INSPECTION WAS PERFORMED ON THE DEVICE. WITH THE EXCEPTION OF FLUID INGRESS BEING OBSERVED IN THE LEFT IUI CAVITY, NO CONTAMINATION OR FLUID INGRESS WAS OBSERVED WITH THE INTERNAL ELECTRONICS OR COMPONENTS. BOTH IUI CONNECTORS WERE OBSERVED TO BE DULL. SLIGHT IMPACT DAMAGE WAS OBSERVED AT LOWER FRONT OF DOOR. REPLACEMENT PARTS WERE OBSERVED TO BE BD PARTS. A REVIEW OF THE PUMP MODULE ERROR LOG REVEALED SEVERAL (B)(4) ERRORS ASSOCIATED TO THE BOTTLE SIDE PRESSURE SENSOR; HOWEVER NO ERRORS WERE OBSERVED FOR THE PATIENT SIDE PRESSURE SENSOR. RESULTS FROM A FUNCTIONAL TEST CONFIRMED AN INCIDENTAL FAULTY UPPER FSO PRESSURE SENSOR. PRESSURE SENSOR MALFUNCTION TEST METHOD RESULTS IDENTIFIED THE PATIENT SIDE PRESSURE SENSOR SLIGHTLY OUT OF SPECIFICATION. HOWEVER, DURING OCCLUSION TESTING, THE PATIENT SIDE PRESSURE SENSOR PASSED, INDICATING THAT THE SENSOR MAY BE EXHIBITING AN INTERMITTENT FAILURE. IT SHOULD BE NOTED THAT BOTH SENSOR WERE FOUND TO BE APPROXIMATELY 8 YEARS OLD. THE PROXIMATE CAUSE OF THE DEVICE FAILING PATIENT SIDE OCCLUSION TESTING DURING PREVENTATIVE MAINTENANCE IS BELIEVED TO BE A MARGINALLY OUT-OF-SPECIFICATION LOWER FSO PRESSURE SENSOR. THE PROXIMATE CAUSE OF THE FAILED FSA PRESSURE SENSOR IS LIKELY RELATED TO AN INTERMITTENT FAILURE WITH THE INTERNAL SENSOR CIRCUITS. A CONTRIBUTING FACTOR HAS BEEN FOUND TO BE EXCESSIVE FORCE APPLIED TO THE SENSOR DURING CLINICAL OPERATION OR DURING HANDLING. DEVICE HISTORY REVIEW: REVIEW OF THE PUMP MODULE S/N (B)(4) SERVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 11/19/2012. A REVIEW OF THE DEVICE SERVICE HISTORY RECORD WAS PERFORMED BEGINNING FROM THE DATE OF MANUFACTURE TO THE PRESENT DATE (B)(6) 2020 AND INDICATED THAT THIS DEVICE HAS NOT BEEN PREVIOUSLY RETURNED FOR SERVICE. REVIEW OF THE PRODUCTION FAILURE RECORD WAS PERFORMED BEGINNING FROM THE DATE OF MANUFACTURE THROUGH PRESENT. THE FAILURE RECORD SHOWED NO PRODUCTION FAILURE RECORDS WERE OPENED FOR THE SOURCE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE FAILED PATIENT SIDE OCCLUSION TESTING, DURING PREVENTATIVE MAINTENANCE AND NOT ON A PATIENT. THERE IS NO INDICATION OF PATIENT INVOLVEMENT OR IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1086334 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1