BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE RESERVOIRS - FLOW STOP

    MDR report key: 9284374 · Received November 6, 2019

    Report

    Report Number
    3012307300-2019-05860
    Event Type
    Malfunction
    Date Received
    November 6, 2019
    Date of Event
    August 16, 2019
    Report Date
    March 11, 2020
    Manufacturer
    SMITHS MEDICAL ASD,INC.
    Product Code
    FPA
    UDI-DI
    10610586027215
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS COMPLETED ON A SMITHS MEDICAL AMBULATORY INFUSION PUMPS/CADD CASSETTE RESERVOIRS - FLOW STOP. PRODUCT WAS NOT RETURNED AND REVIEW WAS DONE ON THE SAMPLES FROM P/N 21-7301-24 L/N UNKNOWN. NO LEAKING WAS OBSERVED WITH PRODUCT AND PICTURES WERE PROVIDED AND ATTACHED. ANALYSIS FROM OTHER PROCESSES WERE REVIEWED ON P/N 21-7301-24 L/N 3891176 BY QUALITY ENGINEER ON 04/NOV/2019. NO LEAKAGE WAS DETECTED. DEVICE PERFORMED 100% DURING MANUFACTURING ASSEMBLY. NO ROOT CAUSE COULD BE ISOLATED TO THE COMPLAINT. ACTION TAKEN TO NOTIFY QUALITY ENGINEER ON EVENT . UPDATE 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

    INVESTIGATION RESULTS COMPLETED ON A SMITHS MEDICAL CADD CASSETTE RESERVOIRS - FLOW STOP. SUMMARY IN H 10.

    Description of Event or Problem · 1

    INFORMATION RECEIVED A SMITH MEDICAL CADD CASSETTE RESERVOIRS - FLOW STOP LEAKED OUTSIDE THE PLASTIC BAG AND INSIDE CASING. PHARMACIST COLLECTED THE PRODUCT AND FOUND MORE LEAKAGE AND HOLES. UNKNOWN WHAT DRUGS WERE INSIDE CASSETTE. NO PATIENT INJURY OR ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1083086 CADD CASSETTE RESERVOIRS - FLOW STOP SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD,INC. RESERVOIR CASSETTE 50 ML 10610586027215

    Patients

    Seq Age Sex Outcome Treatment
    1