BEUDAMED
    FDA Adverse Event Other Summary report: N

    CADD-SOLIS AMBULATORY INFUSION PUMPS

    MDR report key: 2163573 · Received July 11, 2011

    Report

    Report Number
    MW5021314
    Event Type
    Other
    Date Received
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    MEA
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PLEASE REVIEW THE ATTACHED SAFETY ALERT FROM SMITHS MEDICAL CONCERNING CADD-SOLIS AMBULATORY INFUSION PUMP. I THINK THAT THIS IS DANGEROUS WITH THE POTENTIAL FOR PATIENT HARM. DETAILS ON AFFECTED DEVICES: CADD-SOLIS AMBULATORY INFUSION PUMPS. SMITHS MEDICAL IS PROVIDING THIS SAFETY ALERT TO ADVISE ITS CUSTOMERS OF THE ATTACHED CUSTOMER INFO BULLETIN THAT PROVIDES ADD'L INFO FOR CORRECTLY LATCHING THE CADD MEDICATION CASSETTE RESERVOIR OR ADMINISTRATION SET TO THE PUMP. SMITHS MEDICAL HAS BECOME AWARE OF A SMALL NUMBER OF COMPLAINTS FOR SIGNIFICANT UNDER-DELIVERY/ NON-DELIVERY OF FLUIDS WHEN THE CADD MEDICATION CASSETTE RESERVOIR OR ADMINISTRATION SET ("CASSETTE") IS NOT CORRECTLY LATCHED TO THE PUMP. IN SOME CASES, IT IS POSSIBLE FOR THE LATCH LOCK ASSEMBLY ON THE CADD-SOLIS PUMP TO LATCH ON AN INCORRECTLY ATTACHED CASSETTE. BECAUSE THE LATCH HANDLE CAN BE PUSHED TO ITS FULLY UPRIGHT POSITION, EVEN IF THE CASSETTE IS INCORRECTLY ATTACHED, BOTH THE CLINICIAN AND THE PUMP CAN PERCEIVE THAT THE PUMP AND CASSETTE ARE LATCHED UP CORRECTLY. HOWEVER, SINCE THE CASSETTE IS NOT ATTACHED CORRECTLY, THE FLUIDS IN THE RESERVOIR CANNOT BE DELIVERED, OR WILL BE SIGNIFICANTLY UNDER-DELIVERED, EVEN THOUGH THE PUMP INDICATES IT IS DELIVERING. AS LONG AS THE CASSETTE IS CORRECTLY ATTACHED TO THE PUMP, THIS ISSUE WILL NOT OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CADD-SOLIS AMBULATORY INFUSION PUMPS INFUSION PUMP MEA SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1