BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8120 ALARIS PCA

    MDR report key: 10579318 · Received September 24, 2020

    Report

    Report Number
    2016493-2020-09385
    Event Type
    Malfunction
    Date Received
    September 24, 2020
    Date of Event
    January 1, 2018
    Report Date
    January 4, 2018
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K032233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    221939 EVALUATION STATEMENT: THE REPORTED EVENT OF A PATIENT WITH A PCA MODULE AND KEYS COULD NOT BE CONFIRMED. NO PRODUCT OR EVENT LOGS HAVE BEEN RETURNED FOR THIS INVESTIGATION. FILE WAS OPENED TO DOCUMENT AN EVENT THAT THE CUSTOMER REPORTED. NO FURTHER INVESTIGATION OF THIS EVENT IS POSSIBLE AT THIS TIME. A DHR REVIEW CANNOT BE COMPLETED AS THE SERIAL NUMBER WAS NOT OBTAINED UPON RECEIPT OF THE COMPLAINT. ADDITIONALLY A HISTORICAL REVIEW OF COMPLAINTS IN BD2 TRACKWISE CANNOT BE CONDUCTED. CAPA REFERENCE: CA-2018-0171.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A PATIENT PRESENTED WITH HER OWN PCA MODULE AND KEY. THE CUSTOMER INQUIRED HOW THE PATIENT WAS ABLE TO OBTAIN HER OWN MODULE AND KEYS. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION OR REPORT OF A PATIENT EVENT WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4) EVALUATION STATEMENT: THE REPORTED EVENT OF A PATIENT WITH A PCA MODULE AND KEYS COULD NOT BE CONFIRMED. NO PRODUCT OR EVENT LOGS HAVE BEEN RETURNED FOR THIS INVESTIGATION. FILE WAS OPENED TO DOCUMENT AN EVENT THAT THE CUSTOMER REPORTED. NO FURTHER INVESTIGATION OF THIS EVENT IS POSSIBLE AT THIS TIME. A DHR REVIEW CANNOT BE COMPLETED AS THE SERIAL NUMBER WAS NOT OBTAINED UPON RECEIPT OF THE COMPLAINT. ADDITIONALLY A HISTORICAL REVIEW OF COMPLAINTS IN BD2 TRACKWISE CANNOT BE CONDUCTED. CAPA REFERENCE: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT PRESENTED WITH HER OWN PCA MODULE AND KEY. THE CUSTOMER INQUIRED HOW THE PATIENT WAS ABLE TO OBTAIN HER OWN MODULE AND KEYS. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION OR REPORT OF A PATIENT EVENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044743 8120 ALARIS PCA PUMP, INFUSION FRN CAREFUSION SD 8120

    Patients

    Seq Age Sex Outcome Treatment
    1 Female