BEUDAMED
    FDA Adverse Event Death Summary report: N

    CADD SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 16368582 · Received February 13, 2023

    Report

    Report Number
    3012307300-2023-01205
    Event Type
    Death
    Date Received
    February 13, 2023
    Date of Event
    January 23, 2023
    Report Date
    April 6, 2023
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    15019517126600
    PMA / PMN Number
    K111275
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE PRODUCT WAS RETURNED FOR EVALUATION. THE CUSTOMER'S REPORTED PROBLEM WAS NOT DUPLICATED. RUNNING THREE ACCURACY TESTS, THE PUMP WAS FOUND TO BE WITHIN MANUFACTURING SPECIFICATIONS. PRIMING THE DEVICE, THE DOWNSTREAM SENSOR OCCLUDED AT 12 PSI AND THE PRESSURE HELD ALL THREE TIMES. THERE APPEARS TO BE NO VISUAL DEFECTS WITH THE EXPULSOR, VALVES, OR CHASSIS. THE LATCH LOCK WORKED AS IT SHOULD. THE DELIVERY FUNCTIONS AS IT SHOULD. THERE WERE NO ABNORMAL EVENTS AFTER INVESTIGATING THE HISTORY LOGS. A REVIEW OF THE MANUFACTURING DEVICE HISTORY RECORD (DHR) FOR THIS DEVICE FOUND NO CAUSES OR POTENTIAL CAUSES OF THE CUSTOMER REPORTED FAILURE. NO CAUSES OR POTENTIAL CAUSES OF THE CUSTOMER'S REPORTED PROBLEM WERE FOUND DURING THE REVIEW OF SERVICE AND REPAIR RECORDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE A SMITHS MEDICAL PUMP WAS BEING USED WITH THE PATIENT, THE PATIENT EXPERIENCED DIZZINESS, LETHARGY AND VOMITING. THE PATIENT'S FAMILY CALLED 911 AND THE PATIENT WAS TAKEN TO THE HOSPITAL WHERE IT WAS FOUND THAT THE MEDICATION BAG WAS EMPTY. CUSTOMER STATES THE BAG WAS NOT SUPPOSED TO BE EMPTY UNTIL THE NEXT DAY. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND EXPIRED THREE DAYS LATER. THE CUSTOMER TESTED THE PUMP AND THEY DETERMINED THAT THE BAG AND TUBING HAD 12.75ML EVEN THOUGH THE PUMP READ THAT THERE WAS 58ML LEFT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE BAG WAS CONFIRMED TO HAVE BEEN FILLED TO 500 ML. IT WAS MANUALLY PRIMED IN THE CLEAN ROOM; THE PRIMING VOLUME WAS NOT NOTED. IT COULD NOT BE CONFIRMED IF THE BAG UNDER PRESSURE DURING THE INFUSION OR SIGNIFICANTLY HIGHER THAN THE PATIENT; AND IT WAS USED OF THE SAME SET FOR 7 DAYS PRESCRIBED BY THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1387551 CADD SOLIS VIP AMBULATORY INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120 15019517126600

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R| D