BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD SOLIS VIP PUMP

    MDR report key: 14633470 · Received June 8, 2022

    Report

    Report Number
    3012307300-2022-11147
    Event Type
    Malfunction
    Date Received
    June 8, 2022
    Report Date
    October 27, 2022
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    15019517084368
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO SMITHS/ICU MEDICAL.

    Additional Manufacturer Narrative · 0

    OTHER TEXT: H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER: UPDATED. H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION AND FUNCTIONAL TESTS WERE PERFORMED. THE CUSTOMER REPORTED PROBLEM WAS NOT RELATED TO ANY PREVIOUS REPAIR. VISUAL INSPECTION FOUND THE DEVICE MISSING A TAMPER SEAL AND WITH A DENT AIR DETECTOR. THERE WAS NO EVIDENCE OF THE REPORTED PROBLEM RECORDED IN THE EVENT HISTORY LOG. THE CUSTOMER REPORTED PROBLEM WAS VERIFIED/DUPLICATED. RUNNING THREE ACCURACY TESTS, THE PUMP WAS FOUND TO BE OVER DELIVERING TO THE MANUFACTURING SPECIFICATIONS, WHICH WAS THE CAUSE OF THE REPORTED PROBLEM. FOR CORRECTIVE ACTION, THE EXPULSOR WAS REPLACED. THE ROOT CAUSE OF THE REPORTED PROBLEM WAS UNKNOWN. PRODUCT IS BEYOND A YEAR FROM MANUFACTURE DATE AND THERE WAS NO INDICATION OF A MANUFACTURING DEFECT DURING THE INVESTIGATION, SO A DEVICE HISTORY RECORD REVIEW IS NOT REQUIRED. A SERVICE HISTORY REVIEW IDENTIFIED THIS DEVICE HAS NOT BEEN IN FOR SERVICE IN THE PREVIOUS YEAR AND THERE WAS NO INDICATION OF A SERVICE ISSUE DURING THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    H6) ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE EVENT OCCURRED DURING TESTING; THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    ORACLE RO 1233255: IT WAS REPORTED THAT A VOLUME INACCURACY ISSUE OCCURRED; THE PUMP OVER INFUSED. NO PATIENT INJURY WAS REPORTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE EVENT OCCURRED DURING TESTING; THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12435 CADD SOLIS VIP PUMP PUMP, INFUSION FRN ST PAUL 2120 15019517084368

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown