BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 9941931 · Received April 8, 2020

    Report

    Report Number
    3012307300-2020-02734
    Event Type
    Malfunction
    Date Received
    April 8, 2020
    Date of Event
    March 3, 2020
    Report Date
    December 8, 2020
    Manufacturer
    ST PAUL
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION COMPLETED ON A SMITHS MEDICAL AMBULATORY INFUSION PUMPS/CADD ADMINISTRATION SETS - FLOW STOP . THE SAMPLE WAS TESTED FOR LEAKING USING HYDROSTAT. THIS WAS CONFIRMED AND OBSERVED FLEEING FROM THE AIR VENT OF THE FILTER. ROOT CAUSE IN ORDER TO PERFORM A COMPLETE ROOT CAUSE ANALYSIS OF THIS FAILURE MODE, CAPA-000542 WAS OPEN ON (B)(6) 2019, ON WHICH ROOT CAUSE STATES FILTER LEAKAGE IS CAUSED SILICON OIL TRANSFERRED FROM THE SYRINGES AND/OR VIALS INTO MEDICATION RESERVOIR DURING THE FILLING PROCESS BY THE CUSTOMER. ACTION TAKEN BY THE DATE THAT IS INVESTIGATION REPORT IS DOCUMENTED, THIS CAPA-000542 WAS CLOSED ON (B)(6) 2020 AND THE CORRECTIVE ACTION INCLUDED ON THIS INVESTIGATION WAS REMOVED FROM THE SCOPE AND INCLUDED IN PROJECT 100034, THAT IT WILL ADDRESS THIS REPORTED TO INCLUDE ADDITIONAL IFU VERBIAGE TO INFORM CUSTOMER OF THE PRODUCTS THAT SHOULD NOT BE USED WHEN TRANSFERRING FLUID TO THE MEDICATION CASSETTES. THE PROJECT INFORMATION REFERENCE CAN BE FOUND IN CO-10095341.

    Additional Manufacturer Narrative · 0

    EVALUATION RESULTS: ONE CADD LEGACY PUMP WAS RETURNED FOR INVESTIGATION IN USED CONDITION. A FUNCTIONAL CHECK WAS PERFORMED. THE CUSTOMER REPORTED PRODUCT PROBLEM (DISPLAY OF ERROR CODE 1871) WAS CONFIRMED DURING A FUNCTIONAL CHECK. THE PRODUCT PROBLEM WAS ATTRIBUTED TO A BROKEN WIRE. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. THE PROBLEM SOURCE OF THE REPORTED PRODUCT PROBLEM WAS UNKNOWN. A ROOT CAUSE WAS NOT ESTABLISHED. THE BROKEN WIRE WAS SOLDERED.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: INVESTIGATION COMPLETED ON A SMITHS MEDICAL AMBULATORY INFUSION PUMPS/CADD ADMINISTRATION SETS - FLOW STOP. THE SAMPLE WAS TESTED FOR LEAKING USING HYDROSTAT. THIS WAS CONFIRMED AND OBSERVED FLEEING FROM THE AIR VENT OF THE FILTER. ROOT CAUSE IN ORDER TO PERFORM A COMPLETE ROOT CAUSE ANALYSIS OF THIS FAILURE MODE, CAPA-000542 WAS OPEN ON 30-APR-2019, ON WHICH ROOT CAUSE STATES FILTER LEAKAGE IS CAUSED SILICON OIL TRANSFERRED FROM THE SYRINGES AND/OR VIALS INTO MEDICATION RESERVOIR DURING THE FILLING PROCESS BY THE CUSTOMER. ACTION TAKEN BY THE DATE THAT IS INVESTIGATION REPORT IS DOCUMENTED, THIS CAPA-000542 WAS CLOSED ON 23-JUL-2020 AND THE CORRECTIVE ACTION INCLUDED ON THIS INVESTIGATION WAS REMOVED FROM THE SCOPE AND INCLUDED IN PROJECT (B)(4), THAT IT WILL ADDRESS THIS REPORTED TO INCLUDE ADDITIONAL IFU VERBIAGE TO INFORM CUSTOMER OF THE PRODUCTS THAT SHOULD NOT BE USED WHEN TRANSFERRING FLUID TO THE MEDICATION CASSETTES. THE PROJECT INFORMATION REFERENCE CAN BE FOUND IN (B)(4).

    Description of Event or Problem · 0

    INVESTIGATION COMPLETED AND SUMMARY.

    Description of Event or Problem · 0

    INVESTIGATION COMPLETED AND SUMMARY IN H 10.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT DEVICE HAD ERROR 1871. NO ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398523 CADD PUMP, INFUSION FPA ST PAUL 21-7394-24 3860307

    Patients

    Seq Age Sex Outcome Treatment
    1