BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCA PUMP (AUZ)

    MDR report key: 2554383 · Received June 2, 2010

    Report

    Report Number
    2921482-2010-00389
    Event Type
    Malfunction
    Date Received
    June 2, 2010
    Date of Event
    May 5, 2010
    Report Date
    May 5, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    MEA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PASSED TESTING BY DELIVERING A DOSE WHEN THE PT PENDANT WAS PRESSED. THE CUSTOMER'S RETURNED PT PENDANT CORD WAS USED DURING THE TESTING PROCEDURES. THE HISTORY WAS DOWNLOADED AT THE SVC CTR. A REVIEW OF THE DEVICE HISTORY INDICATED THAT ON (B)(6) 2010 BETWEEN 0720 AND 1014, THERE WERE 5 PT INITIATED DELIVERIES. THE CATALOG NUMBER PROVIDED IS THE INTL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER 01950. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FRN AND HAS A 510K OF K912928. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE DEVICE DID NOT DELIVER A DOSE WHEN THE PT PENDANT WAS PRESSED. THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF FENTANYL. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. AFTER APPROX 3 HOURS, IT WAS NOTED THAT THE PT PUSHED THE BUTTON ON THE PT PENDANT A DOSE WAS NOT DELIVERED. THE DEVICE WAS REMOVED FROM CLINICAL SVC. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA PUMP (AUZ) UNK MEA HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1