BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD S

    MDR report key: 14545166 · Received May 30, 2022

    Report

    Report Number
    3012307300-2022-10053
    Event Type
    Malfunction
    Date Received
    May 30, 2022
    Report Date
    October 24, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    15019517126600
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OPERATOR OF DEVICE IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED TO MANUFACTURING FOR INVESTIGATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED. VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THAT THE AIR DETECTOR EXHIBITED A SMALL DENT UPON RECEIPT. ERROR CODE WAS FOUND IN THE EHL (EVENT HISTORY LOG). THE CUSTOMER REPORTED PROBLEM WAS DUPLICATED DURING THE INVESTIGATION, THE AIR DETECTOR WAS NOT FUNCTIONING PROPERLY. ROOT CAUSE OF THE REPORTED EVENT IS UNKNOWN HOWEVER, A SMALL DENT WAS FOUND ON THE AIR DETECTOR. THE AIR DETECTOR WILL NEED TO BE REPLACED. THE RETURNED PRODUCT IS BEYOND A YEAR FROM THE MANUFACTURE DATE AND THERE WAS NO INDICATION OF A MANUFACTURING DEFECT DURING THE INVESTIGATION, SO A DEVICE HISTORY RECORD DHR REVIEW IS NOT REQUIRED., CORRECTED DATA: D4: CORRECTION: CATALOG NUMBER: 21-2127-0104-01, D4: CORRECTION: MODEL NUMBER: 2120, H4: CORRECTION: DEVICE MANUFACTURE DATE: UPDATED.

    Additional Manufacturer Narrative · 0

    B5: ADDITIONAL INFORMATION RECEIVED BY SMITHS MEDICAL/ICU ON 03-JUL-2022 VIA EMAIL: EVENT DID NOT OCCUR WHILE IN USE BY PATIENT. FOUND DURING TESTING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE KEEPS ALARMING AIR IN LINE WHEN THERE IS NO AIR THE LINE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1660583 CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD S PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120 15019517126600

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown