BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 14578311 · Received June 2, 2022

    Report

    Report Number
    3012307300-2022-10536
    Event Type
    Malfunction
    Date Received
    June 2, 2022
    Report Date
    October 28, 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
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED BY SMITHS MEDICAL/ICU ON 23-MAY-2022 VIA EMAIL AND ATTACHED TO COMPLAINT OBJECT: THE EVENT DID NOT OCCUR DURING USE WITH A PATIENT. FOUND DURING TESTING.

    Additional Manufacturer Narrative · 0

    OTHER, 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 IN GOOD CONDITION WITH NO APPEARANCE OF ANY PHYSICAL DAMAGE; HOWEVER THE TAMPER SEAL WAS MISSING. THERE WAS NO EVIDENCE OF THE REPORTED PROBLEM RECORDED IN THE EVENT HISTORY LOG. THE CUSTOMER REPORTED PROBLEM WAS VERIFIED/DUPLICATED. DURING TESTING, THE AIR DETECTOR READ AIR-IN-LINE, AND THIS WAS FOUND TO BE THE CAUSE OF THE REPORTED AS IT WAS INOPERABLE. FOR CORRECTIVE ACTION THE AIR DETECTOR 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. SERVICE REVIEW IDENTIFIED THIS DEVICE HAS NOT BEEN IN FOR SERVICE PREVIOUSLY., CORRECTED DATA: CORRECTION: CATALOGUE NUMBER: 21-2127-0104-01.

    Description of Event or Problem · 0

    AIR IN LINE SENSOR INOPERABLE WAS EXPERIENCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227766 CADD PUMP,INFUSION FRN SMITHS MEDICAL ASD, INC. 2120 15019517126600

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown