BEUDAMED
    FDA Adverse Event Death Summary report: N

    CADD-SOLIS AMBULATORY INFUSION PUMP, GERMAN

    MDR report key: 19996855 · Received August 15, 2024

    Report

    Report Number
    3012307300-2024-07714
    Event Type
    Death
    Date Received
    August 15, 2024
    Date of Event
    July 1, 2024
    Report Date
    September 23, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    MEA
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B2: UNKNOWN; NO INFORMATION HAS BEEN PROVIDED TO DATE. B3: UNKNOWN; NO INFORMATION HAS BEEN PROVIDED TO DATE. PER REPORTER, THE DEVICES ARE NOT AVAILABLE FOR INVESTIGATION AS THEY ARE BEING RETAINED AT THE FACILITY AS PART OF THE POLICE INVESTIGATION. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    D9: PRODUCT RECEIVED DATE: 26-JULY-2024 H3: ONE DEVICE WAS RETURNED FOR EVALUATION IN GOOD CONDITION. VISUAL EVALUATION FOUND NO PHYSICAL DAMAGE TO THE PUMP. THE DOWNSTREAM OCCLUSION (DSO) SEAL WAS DELAMINATED. REVIEW OF DEVICE'S SERVICE HISTORY WAS NOT PERFORMED. THE DSO SEAL WAS REPLACED. THE DEVICE PASSED FUNCTIONAL AND DELIVERY TESTS.

    Description of Event or Problem · 0

    PER REPORTER, THIS IS ONE OF EIGHT CADD-SOLIS PUMPS INVOLVED IN ONE OR MORE PATIENTS' DEATH, WHICH ARE NOW PART OF A POLICE CASE. A NURSE IS BEING INVESTIGATED AS THE CAUSE OF THE PATIENTS' DEATH. THE REPORTER HAS INFORMED US THAT THERE IS NO EVIDENCE OF A PRODUCT DEFECT CONTRIBUTING TO THESE INCIDENTS. PER REPORTER, NO ADDITIONAL INFORMATION ABOUT THE NUMBER OF AFFECTED PATIENTS, OR ANY DETAILS SURROUNDING THE INCIDENTS, OR THE INVESTIGATION, CAN BE SHARED WITH US AT THIS TIME. PER REPORTER, THE DEVICES ARE NOT AVAILABLE FOR INVESTIGATION AS THEY ARE BEING RETAINED AT THE FACILITY AS PART OF THE POLICE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2361741 CADD-SOLIS AMBULATORY INFUSION PUMP, GERMAN PUMP, INFUSION, PCA MEA SMITHS MEDICAL ASD, INC. 2110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death