BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS VIP PUMP

    MDR report key: 9517737 · Received December 25, 2019

    Report

    Report Number
    3012307300-2019-06892
    Event Type
    Malfunction
    Date Received
    December 25, 2019
    Report Date
    December 25, 2019
    Manufacturer
    SMITHS MEDICAL ASD,INC
    Product Code
    FRN
    UDI-DI
    01501951712658
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS COMPLETED ON A SMITHS MEDICAL CADD SOLIS VIP 2120 PUMP. PUMP WAS VISUALLY ASSESSED AND REVEALED DAMAGED LENS. DOWN STREAM BUBBLED AND BATTERY COMPARTMENT DAMAGED. EVENT LOG WAS ABLE TO VALIDATE COMPLAINT WITH ALARM LEC LEC 41627. WHEN EVALUATION AND TESTS WERE DOWN ON DEVICE, THE COMPLAINT WAS NOT VERIFIED BUT NOTED TO HAVE EXCESSIVE NOISE WHEN POWERING ON. ACTION WAS TAKEN TO REPLACE MOTOR FOR PREVENTATIVE MEASURES.

    Description of Event or Problem · 1

    INFORMATION RECEIVED A SMITHS MEDICAL CADD SOLIS 2120 PUMP ALARMING LEC 41627 . NO PATIENT INVOLVEMENT IN EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1312110 CADD SOLIS VIP PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD,INC 2120 01501951712658

    Patients

    Seq Age Sex Outcome Treatment
    1