BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFECARE PCA 3 V5.06

    MDR report key: 3770771 · Received February 18, 2014

    Report

    Report Number
    9615050-2014-01232
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    January 22, 2014
    Report Date
    January 22, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    MEA
    PMA / PMN Number
    K042800
    Removal / Correction Number
    FA301-02
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER PERFORMED TESTING AND INVESTIGATION AT THE USER FACILITY. DURING TESTING, THE DEVICE PASSED TESTING. AN E630 (SCREW ROTATION ERROR) ERROR CODE WAS NOTED IN THE DEVICE HISTORY BUT WAS NOT DUPLICATED DURING TESTING. ALTHOUGH THE DEVICE PASSED TESTING, THIS DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE DEVICE ALARMED WITH AN E630 (SCREW ROTATION ERROR) ERROR CODE. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT FOR A REPORT OF SCREW ROTATION ERROR. NO TRACKING INFORMATION WAS PROVIDED; THEREFORE, SPECIFIC PATIENT INFORMATION, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, AN E630 (SCREW ROTATION ERROR) ERROR CODE WAS NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101452 LIFECARE PCA 3 V5.06 80MEA MEA HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK