BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CADD PUMP SOLIS VIP

    MDR report key: 23545215 · Received November 12, 2025

    Report

    Report Number
    MW5178857
    Event Type
    Injury
    Date Received
    November 12, 2025
    Date of Event
    November 7, 2025
    Report Date
    November 8, 2025
    Manufacturer
    ICU MEDICAL, INC./SMITHS MEDICAL
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    (B)(6). PHARMACY TECH FROM HOSPITAL REPORTED WAS IN ER AND THEN ADMITTED TODAY DUE TO UNSPECIFIED PUMP ALARM. DATE OF DISCHARGE OR CURRENT LENGTH OF HOSPITALIZATION IS UNKNOWN. NO FURTHER INFORMATION, DETAILS OR DATES AVAILABLE. PUMP SERIAL NUMBER PROVIDED: (B)(6), EXPIRATION UNKNOWN. PUMP RETURN TRACKING INFORMATION IS NOT AVAILABLE. PHOTOGRAPHS WERE NOT PROVIDED. POSITION OF PUMP WHEN ALARM OCCURRED IS UNKNOWN. THIS IS A CONTINUOUS INFUSION. SET FLOW RATE AND VOLUME DELIVERED ARE UNKNOWN. PRODUCT LOT AND EXPIRATION UNKNOWN. UNKNOWN IF MD IS AWARE. DOSE/AMOUNT: VELETRI SDV - 50NG/KG/MIN. IF PROVIDED ON THE FORM, THE PRODUCT LOT NUMBER AND EXPIRATION WERE SYSTEMATICALLY RETRIEVED FROM THE DISPENSING SYSTEM. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH PT? UNKNOWN. DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PT OR CLINICAL INJURY UNKNOWN. IS THE ACTUAL DEVICE AVAILABLE FOR INVESTIGATION? UNKNOWN. DID PHARMACY REPLACE DEVICE? UNKNOWN. DID THE PT HAVE A BACKUP DEVICE THEY WERE ABLE TO SWITCH TO? UNKNOWN. IS THE INFUSION LIFE-SUSTAINING? YES. OUTCOME? UNKNOWN. PULMONARY ARTERIAL HYPERTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1922934 CADD PUMP SOLIS VIP PUMP, INFUSION FRN ICU MEDICAL, INC./SMITHS MEDICAL 2120

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female Hospitalization AMBRISENTAN.| WINREVAIR SDV.