BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE RESERVOIR

    MDR report key: 10045053 · Received May 11, 2020

    Report

    Report Number
    3012307300-2020-04038
    Event Type
    Malfunction
    Date Received
    May 11, 2020
    Date of Event
    January 30, 2020
    Report Date
    July 10, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    UDI-DI
    10610586027239
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTS OF LEAKING PRIOR TO USE IS NON REPORTABLE ACCORDING TO HAZARD CODE RMD-10001875.106-DELAY OF THERAPY - MINOR-HAZSIT.380. THE EVENT WITH THREE REALATED FILES DISCRIBED THAT IT WHILE PREPARING MEDICATION AND THE DEVICE DID NO REACH THE HOME CARE PATIENT. THIS FILE IS CONSIDERED NON REPORTABLE AS NO PATIENT HARM OCCURRED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: INVESTIGATION COMPLETED ON A SMITHS MEDICAL AMBULATORY INFUSION PUMPS/CADD CASSETTE RESERVOIRS - FLOW STOP. THE DEVICE WAS VISUALLY INSPECTED WITH CASSETTE SAMPLE HAVING A MEDICATION INFORMATION LABEL ON IT. WHEN FUNCTIONAL TESTING WAS DONE BY TAKING A SYRINGE AND INFUSE WATER INTO THE AY BAG A LEAK WAS DETECTED, SPECIFICALLY LOCATED IN THE TOP CORNER NEAR PUMP TUBE CONNECTION. A REVIEW ON AMBULATORY INFUSION PUMPS/CADD CASSETTE RESERVOIRS - FLOW STOP FOR P/N 21-7302-24 L/N 3983326 WAS CONDUCTED BY QUALITY ENGINEER ON (B)(6) 2020, IN ORDER TO VERIFY THAT THERE ARE NO SITUATIONS OR PRACTICES THAT COULD CREATE THE EVENT AS DESCRIBED IN "COMPLAINT DESCRIPTION" SECTION. THE ITEMS PERFORMED IN THE QUALITY REVIEW 100 %. UNKNOWN CAUSE OF LEAK RELATED TO THIS EVENT. ENGINEERS AWARE AND WILL CONTINUE MONITORING PRACTICES. CORRECTIVE DATA : FILE IS CHANGED BACK TO REPORTABLE MALFUNCTION AS LEAK IN INNER POUCH MAY NOT BE DETECTED UNTIL REACHING PATIENT ANY MAY CAUSE HARM TO PATIENT WITH UNDER DELVIERY AND TOXICITY IF MEDICATION IS CONSIDERED TOXIC. THIS IS A CORRECTION FROM THE PRIOR SUPPLMENTAL SENT. UPDATED FIELDS. B 1. B 4. B 5. D 10. G 7. H 1. H 2. H 3. H 6 H 10.

    Description of Event or Problem · 0

    CORRECTION ON FILE.

    Description of Event or Problem · 0

    INVESTIGATION COMPLETED ON AMBULATORY-INFUSION PUMPS CADD CASSETE RESERVOIRS-FLOW STOP . SUMMARY IN H 10. CORRECTION DATA ALSO IMPLEMENTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD CASSETTE RESERVOIR HAD A LEAK IN THE INNER POUCH. THE LEAK WAS DISCOVERED DURING PREPARATION OF MEDICATION AND THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507509 CADD CASSETTE RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 21-7302-24 3808553 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1