BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 15232764 · Received August 16, 2022

    Report

    Report Number
    3012307300-2022-15406
    Event Type
    Malfunction
    Date Received
    August 16, 2022
    Date of Event
    October 8, 2021
    Report Date
    November 9, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    15019517126587
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS NOT CONDUCTED, BASED UPON REVIEW OF THE INFORMATION PROVIDED BY THE CUSTOMER, AS IT DOES NOT INDICATE A PROBLEM WITH THE INITIAL MANUFACTURE OR PRIOR REPAIR OF THE DEVICE. NO PRODUCT SAMPLE WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE REPORTED ISSUE COULD NOT BE CONFIRMED AS NO PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: H6: EVENT PROBLEM AND EVALUATION CODES: UPDATES NOT REQUIRED. H3: DEVICE EVALUATED BY MANUFACTURER: UPDATED. NO PRODUCT OR PHOTOGRAPHIC EVIDENCE WAS PROVIDED TO AID IN THIS INVESTIGATION. THE COMPLAINT REPORT OFFERED INSUFFICIENT DETAILS TO DETERMINE WHETHER THIS PRODUCT FUNCTIONED AS INTENDED OR WAS USED IN A MANNER CONSISTENT WITH ITS INSTRUCTIONS FOR USE (IFU) OR FAILED TO MEET PRODUCT SPECIFICATIONS. LACKING ANY ADDITIONAL EVIDENCE, THIS COMPLAINT HAS BEEN CLOSED AS UNCONFIRMED. IF THE PRODUCT IS RETURNED, SMITHS MEDICAL WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS NOT CONDUCTED, BASED UPON REVIEW OF THE INFORMATION PROVIDED BY THE CUSTOMER, AS IT DOES NOT INDICATE A PROBLEM WITH THE INITIAL MANUFACTURE OR PRIOR REPAIR OF THE DEVICE., CORRECTED DATA: CORRECTIONS: D4: CATALOG AND MODEL NUMBER: 21-2120-0104-01 / 2120.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS RECEIVING EPOCH. FIELD NURSE REPORTED THAT HALF OF THE BAG OF EPOCH WAS NOT INFUSED AT THE TIME OF BAG CHANGE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2288222 CADD-SOLIS VIP AMBULATORY INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120 15019517126587

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female