BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 5178689 · Received October 26, 2015

    Report

    Report Number
    9616066-2015-01401
    Event Type
    Malfunction
    Date Received
    October 26, 2015
    Date of Event
    September 29, 2015
    Report Date
    January 16, 2025
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S EXPERIENCE WITH THE SAFETY CLAMP NOT ENGAGING WHEN REMOVING THE TUBING FROM THE DEVICE WAS NOT CONFIRMED. A REVIEW OF THE PCU EVENT LOG RECORDED 12 FLO_STOP_OPEN ALARMS ON THE PUMP MODULE BETWEEN (B)(6) 2015 AND (B)(6) 2015. THERE WERE NO FLO_STOP_OPEN ALARMS EXHIBITED ON THE DATE OF THE REPORTED EVENT. FUNCTIONAL TESTING WAS PERFORMED, A TEST INFUSION WITH THE PUMP MODULE LOADED WITH THE RETURNED ADMINISTRATION SET COMPLETED WITHOUT ANY FLOW STOP OPEN ALARMS OR ANOMALIES. FURTHER TESTING OF THE DOOR LATCH WAS PERFORMED TO OBSERVE THE FUNCTIONING OF THE FLOW STOP SLIDE. NO ISSUES OR ANOMALIES WERE OBSERVED DURING THIS TEST. THE PROXIMATE CAUSE OF THE SAFETY CLAMP NOT ENGAGING WHEN THE DOOR IS OPEN IS BELIEVED TO BE RELATED TO THE CENTERED POSITION OF THE SEAR PIVOT POINT DESIGN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THE SAFETY CLAMP DID NOT ENGAGE WHEN REMOVING THE TUBING FROM THE DEVICE, CAUSING UNINTENDED FLOW IN THE ICU. THE ISSUE WAS REPLICATED AFTER THE EVENT, STATING THE WHITE PART OF THE SAFETY CLAMP WAS PULLED FORWARD PARTIALLY, BUT NOT ENOUGH TO STOP THE FLUID BOLUS. THE ROLLER CLAMP SHOULD BE USED AS PRIMARY FREE FLOW PREVENTION, HOWEVER IT WAS NOT ENGAGED AT THE TIME OF THE EVENT .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707239 ALARIS PUMP MODULE ADMINISTRATION SET PUMP, INFUSION FRN CAREFUSION 8100
    707271 ALARIS PUMP MODULE ADMINISTRATION SET PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 8015,8100, THERAPY DATE (B)(6) 2015