BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-PRIZM PCS AMBULATORY INFUSION PUMP

    MDR report key: 5124841 · Received May 28, 2004

    Report

    Report Number
    2183502-2004-00041
    Event Type
    Malfunction
    Date Received
    May 28, 2004
    Manufacturer
    SMITHS MEDICAL MD
    Product Code
    MEA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ALLEGED DEVICE WAS RETURNED AND EVALUATED. DELIVERY ACCURACY TESTS WERE PERFORMED, THE DEVICE WAS FOUND TO PASS ALL ACCURACY TESTS. THE PUMP HISTORY WAS DOWNLOADED AND ANALYZED, THE PUMP HISTORY INDICATES THAT THE UNIT WAS OPERATING PROPERLY. EVALUATION OF THE PUMP FOUND THE DEVICE TO MEET OR EXCEED ALL CURRENT MANUFACTURER'S SPECIFICATIONS FOR PERFORMANCE AND SAFETY. AS PER DIRECTION RECEIVED FROM THE FDA ON 12/09/1999, THE MANUFACTURER COMPLETES IN IT'S ENTIRETY REGARDLESS IF THE USER FACILITY COMPLETES ALL OR ANY, THEREFORE, MAY CONTAIN CORRECTED AND/OR ADDITIONAL DATA.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CADD-PRIZM PCS AMBULATORY INFUSION PUMP AMBULATORY INFUSION PUMP MEA SMITHS MEDICAL MD 6101 NA

    Patients

    Seq Age Sex Outcome Treatment
    1