BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    :CADD SOLIS HPCA PUMP

    MDR report key: 16722263 · Received April 12, 2023

    Report

    Report Number
    3012307300-2023-03943
    Event Type
    Malfunction
    Date Received
    April 12, 2023
    Report Date
    September 23, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    UDI-DI
    15019517154986
    PMA / PMN Number
    K170982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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

    OTHER, OTHER TEXT: DEVICE EVALUATION: WE RECEIVED ONE DEVICE FOR INVESTIGATION. VISUAL INSPECTION PERFORMED AND DEVICE WAS RECEIVED IN GOOD CONDITION, APART FROM A BUBBLED DSO. FUNCTIONAL TESTS PERFORMED AND FOUND ACCURACY TEST FAILED, IT WAS TOO HIGH. THE REPORTED EVENT WAS DUPLICATED. SERVICE HISTORY REVIEW IDENTIFIED THERE WAS NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. FOR ALL ENQUIRIES OR FOLLOW-UP QUESTIONS RELATED TO THE RECORD, DO NOT USE [email protected] LOCATED IN SECTIONS G.1., PLEASE DIRECT THOSE TO THE FOLLOWING: [email protected].

    Additional Manufacturer Narrative · 0

    WHILE PERFORMING A REVIEW OF ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER, THERE WAS NO PATIENT INVOLVEMENT, THEREFORE, NO PATIENT DEATH, SERIOUS INJURY, AND NO EVIDENCE OF A REPORTABLE PRODUCT MALFUNCTION. THE HAZARDOUS SITUATION FOR THE GIVEN COMPLAINT DEVICE WOULD NOT LIKELY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. FILE CC-0191349 IS NO LONGER CONSIDERED REPORTABLE, PLEASE DISREGARD ANY REPORTS ASSOCIATED WITH IT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PUMP WAS SHOWING LOW ACCURACY. NO PATIENT INJURY REPORTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2284523 :CADD SOLIS HPCA PUMP PUMP, INFUSION FPA SMITHS MEDICAL ASD, INC. 21-2111-0402-51L 15019517154986

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown