BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 10330085 · Received July 27, 2020

    Report

    Report Number
    3012307300-2020-07581
    Event Type
    Malfunction
    Date Received
    July 27, 2020
    Report Date
    October 23, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    15019517126587
    PMA / PMN Number
    K111275
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: A1, H6. INFORMATION WAS RECEIVED INDICATING THAT THE DEVICE DID NOT FAIL WHILE IN USE WITH A PATIENT. NO PATIENT WAS INVOLVED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS COMPLETED ON A AMBULATORY INFUSION PUMPS/CADD SOLIS VIP PUMPS - 2120 . THE COMPLAINT OF CASSETTE NOT ATTACHED WAS NOT DUPLICATED DURING TESTING. HOWEVER, THE EVENT WAS REVEALED IN THE EVENT LOG. THE CUSTOMER HAS HAD SEVERAL COMPLAINTS ON SAME ISSUE. THE CAUSE IS ISOLATED TO DOWN STREAM OCCLUSION SENSOR. UNKNOWN CAUSE OF EVENT. ACTION WAS TAKEN TO REPLACE THE DOWN STREAM SENSOR. DEVICE THEN PASSED ALL FUNCTIONAL TESTING.

    Description of Event or Problem · 0

    ORACLE RO 1078635: NOT DETECTING CASSETTE **REPEAT REPAIR** ORIGINAL RO 1071607 AND ALSO CAME IN ON RO 1056954 FOR THE SAME ISSUE IN APRIL 2020, PLEASE INVESTIGATE DEVICE THIS IS THE THIRD TIME IT'S COMING FOR SERVICE ON THE SAME ISSUE. ADDITIONAL INFORMATION RECEIVED BY SMITHS MEDICAL ON 28-JUL-2020 ATTACHED IN COMPLAINT OBJECT: NO PATIENT INVOLVED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PUMP WAS NOT DETECTING THE CASSETTE. THERE WERE NO REPORTED ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793759 CADD FRN SMITHS MEDICAL ASD, INC. 2120 15019517126587

    Patients

    Seq Age Sex Outcome Treatment
    1