BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM PUMP MODULE

    MDR report key: 882181 · Received July 13, 2007

    Report

    Report Number
    2016493-2007-00032
    Event Type
    Malfunction
    Date Received
    July 13, 2007
    Date of Event
    June 13, 2007
    Report Date
    June 13, 2007
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER EXPERIENCED A PREVIOUS ISSUE WITH A MISASSEMBLED (BENT) OCCLUDER SPRING, MDR # 2016493-2007-00007. AS PART OF THE FAILURE INVESTIGATION FOR THAT EVENT, AN X-RAY PROCESS WAS DESIGNED AND VALIDATED IN ORDER TO EXAMINE MECHANISM SPRINGS IN THE CUSTOMER'S OTHER DEVICES WITHOUT HAVING TO OPEN EACH DEVICE. X-RAY VIEW OF DEVICE IN THIS REPORT APPEARED TO SHOW A SPRING COIL MISSING OVER THE TOP LEFT OCCLUDER POST. DEVICE WAS RETURNED TO CARDINAL FOR FURTHER TESTING. FUNCTIONAL TESTING WAS PERFORMED WITH RESPECT TO RATE ACCURACY AND OCCLUSION PRESSURE; RATE ACCURACY TESTING SHOWED DEVICE TO BE OUT OF SPECIFICATION BY +38.3%. THE SERVICE SEAL ON THIS DEVICE HAD BEEN BROKEN, INDICATING THAT IT HAD BEEN OPENED OUTSIDE OF THE CARDINAL SERVICE DEPOT. A REVIEW OF THE DEVICE'S HISTORY INDICATES THAT IT WAS BUILT 08/2001. SINCE THE INITIAL BUILD THE DEVICE HAS NEVER BEEN RETURNED TO CARDINAL FOR ANY TYPE OF SERVICE. WHEN THE DEVICE WAS OPENED IT WAS VERIFIED THAT THE TOP LEFT OCCLUDER SPRING WAS MISSING. WHEN A NEW SPRING WAS INSTALLED AND THE DEVICE WAS RE-TESTED FOR RATE ACCURACY THE DEVICE TESTED WITHIN SPECIFICATIONS. ROOT CAUSE OF THE RATE INACCURACY WAS DETERMINED TO BE THE RESULT OF THE MISSING SPRING. THIS INSTRUMENT WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION OF CORRECTIVE AND PREVENTIVE ACTION CURRENTLY IN PLACE TO ADDRESS THIS ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR