BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM PUMP MODULE

    MDR report key: 1121949 · Received August 13, 2008

    Report

    Report Number
    2016493-2008-00109
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 24, 2008
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4).

    Description of Event or Problem · 1

    DEVICE WAS PREVIOUSLY SEEN (B) (6) 2008 FOR SERVICE, AND WAS RETURNED TO CUSTOMER AFTER CARDINAL HEALTH (CAH) SERVICE PERFORMED BOARD UPGRADES AND X-RAY INSPECTION. WHEN CAH FIELD SERVICE TEAM WAS PERFORMING CHECK-IN, DEVICE WAS OBSERVED TO HAVE UNREGULATED FLOW AND WAS OUT OF SPECIFICATION. DEVICE WAS NOT USED ON A PATIENT, WAS RETURNED TO CAH SERVICE FOR EVALUATION. THE FIELD SERVICE REPORT OF UNREGULATED FLOW WAS VERIFIED AND DUPLICATED DURING INVESTIGATION. PRIOR TO PERFORMING FUNCTIONAL TESTING THE DEVICE WAS INSPECTED AS RECEIVED. THE INSTRUMENT SEAL WAS INTACT, NO ISSUES OR ANOMALIES WERE OBSERVED. FUNCTIONAL TESTING FOR UPPER OCCLUDER PRESSURE, PATIENT SIDE OCCLUSION PRESSURE AND RATE ACCURACY WAS PERFORMED; THE DEVICE'S PERFORMANCE WAS FOUND TO BE OUT OF SPECIFICATION, AND THE OBSERVATION BY THE FIELD SERVICE TEAM THAT THE DEVICE EXHIBITED UNREGULATED FLOW DURING TESTING WAS CONFIRMED. FOLLOWING TESTING THE DEVICE WAS DISASSEMBLED AND INSPECTED. THE DEVICE EXHIBITED EVIDENCE OF FLUID INGRESS ON THE REAR COVER AND ON THE BEZEL. THE MECHANISM FRAME WAS REMOVED AND ALL FOUR OCCLUDER SPRINGS WERE PRESENT AND PROPERLY INSTALLED. THE FLUID HAD MIGRATED ONTO THE MECHANISM PUMPING FINGERS AND AROUND THE UPPER OCCLUDER FINGER; IT APPEARED TO HAVE ENTERED AROUND THE BEZEL MEMBRANE. THE FLUID CONTAMINATION ON THE UPPER OCCLUDER FINGER RESULTED IN THE FINGER STICKING IN THE OPEN POSITION, THUS NOT PINCHING AGAINST THE DISPOSABLE SET PROPERLY. THE ROOT CAUSE FOR THE FAILURE OF UNREGULATED FLOW WAS FLUID INGRESS INTO THE DEVICE. CUSTOMER WAS NOTIFIED OF INVESTIGATION FINDINGS. DEVICE HAS NEVER BEEN REPORTED IN THEIR SYSTEM AS HAVING ANY INFUSION RATE INACCURACIES. DEVICE WAS ROUTED BACK TO CUSTOMER THROUGH CARDINAL SERVICE; SERVICE DEPOT TO REPLACE ALL PARTS CORRODED AND CONTAMINATED BY FLUID INGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SYSTEM PUMP MODULE FRN, INFUSION PUMP FRN CARDINAL HEALTH ALARIS PRODUCTS 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1