BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS HPCA AMBULATORY INFUSION PUMP

    MDR report key: 8901375 · Received August 16, 2019

    Report

    Report Number
    3012307300-2019-03917
    Event Type
    Malfunction
    Date Received
    August 16, 2019
    Report Date
    October 8, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    MEA
    UDI-DI
    10610586038778
    PMA / PMN Number
    K130394
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: CONCOMITANT MEDICAL PRODUCTS. DEVICE EVALUATION: ONE SMITHS MEDICAL CADD SOLIS HPCA PUMP WAS RETURNED FOR ANALYSIS WITH A DAMAGED LENS. DURING ANALYSIS, THE CUSTOMER'S REPORTED PROBLEM REGARDING "FAILED ACCURACY TEST" WAS NOT CONFIRMED. THE UNIT PASSED ALL THREE TESTS WITH AN AVERAGE OF +1.11% AND THE RANGE IS +/-3%. NO FURTHER ACTIONS REQUIRED FOR PRIMARY CONCERN AT THIS TIME. BASED ON THE EVIDENCE, THE COMPLAINT WAS NOT CONFIRMED, AND THE PROBLEM SOURCE OF THE REPORTED EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE "FAILED ACCURACY TEST". NO ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695939 CADD-SOLIS HPCA AMBULATORY INFUSION PUMP PUMP, INFUSION, PCA MEA SMITHS MEDICAL ASD, INC. 2111 10610586038778

    Patients

    Seq Age Sex Outcome Treatment
    1