BEUDAMED
    FDA Adverse Event Death Summary report: N

    CADD

    MDR report key: 14315076 · Received May 7, 2022

    Report

    Report Number
    3012307300-2022-07929
    Event Type
    Death
    Date Received
    May 7, 2022
    Date of Event
    April 15, 2022
    Report Date
    June 9, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    15019517150001
    PMA / PMN Number
    K111275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: NO PRODUCT WAS RETURNED. WE ARE UNABLE TO CONFIRM THE REPORTED COMPLAINT. IF THE PRODUCT IS RETURNED, SMITHS MEDICAL WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    OTHER TEXT: ADDITIONAL EVENT INFORMATION EMAILS RECEIVED (UPDATED B5). D5 IS UNKNOWN, NO INFORMATION PROVIDED TO DATE.

    Description of Event or Problem · 0

    COMPLAINT FILE (B)(4) STATES A PATIENT DEATH. THIS COMPLAINT WAS REPORTED BY OPTION HEALTHCARE ON (B)(6) 2022 REGARDING CADD SOLIS VIP PUMPS (P/N 21-2120-0105-01, S/N (B)(4)) AND (P/N 21-2120-0102-51, S/N (B)(4)). EVENT DATE ACCORDING TO COMPLAINT FORM IS (B)(6) 2022. SERIOUS ADVERSE EVENT AND POSSIBLE DEATH. VERY LITTLE INFORMATION REGARDING THE EVENT IS KNOWN/PROVIDED ONLY STATES THE PATIENT DIED. THE MEDICAL CENTER STATES REGULATORY/ COMPETENT AUTHORITY HAVE BEEN INFORMED. THEY ARE REQUESTING THE LOGS OF THE PUMPS TO BE DOWNLOADED AS A SEARCH WARRANT HAS BEEN ISSUED BY THE STATE OF (B)(6). DATE OF DEATH IS UNKNOWN.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED VIA EMAIL 09-MAY-2022 AND ATTACHED TO COMPLAINT: CUSTOMER IS ASKING US TO PROVIDE THE EHL - IT SOUNDS LIKE THERE MIGHT BE A SEARCH WARRANT AT ISSUE HERE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL 11-MAY-2022 AND ATTACHED TO COMPLAINT: LEGAL TEAM REP WAS ABLE TO DISCUSS THIS MATTER WITH CUSTOMER. THERE IS NO ALLEGATION THAT THE PUMPS MALFUNCTIONED. THE EVENT HISTORY LOG (EHL) DOWNLOADS ARE NEEDED AS PART OF A CRIMINAL INVESTIGATION. THE PUMPS WILL BE RETURNED TO MANUFACTURER TO DOWNLOAD THE EVENT HISTORY LOG (EHL) AND PROVIDE THEM TO CUSTOMER AS SOON AS POSSIBLE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM CUSTOMER (DIRECTOR-QUALITY AND RISK MANAGEMENT) ON 12-MAY-2022 AND ATTACHED TO COMPLAINT: WE WILL NOT BE SENDING THESE PUMPS TO YOU FOR DOWNLOAD. PLEASE CALL ME DIRECTLY IF YOU HAVE ANY QUESTIONS OR CONCERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1100159 CADD PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 21-2120-0105-01 15019517150001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death