BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ DRIVER ED 2

    MDR report key: 3802772 · Received February 21, 2014

    Report

    Report Number
    9615050-2014-01404
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 28, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    Z-0624-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THAT THE DEVICE DOOR ROLLER WAS MISSING AND THE DOOR ROLLER PIN WAS BROKEN. FURTHER TESTING, FOUND THE DEVICE HAD UNRESTRICTED FLOW WHEN THE DOOR WAS OPENED. THIS WAS DUE TO THE MISSING DEVICE DOOR ROLLER AND BROKEN DOOR ROLLER PIN. THE MISSING DEVICE DOOR ROLLER AND BROKEN DOOR ROLLER PIN PREVENTED PROPER ACTUATION OF THE REGULATORY CLOSER ON THE DEVICE MECHANISM CAUSING UNRESTRICTED FLOW WHEN THE DOOR WAS OPENED. THE 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 THAT DURING TESTING AT THE USER FACILITY, IT WAS NOTED THAT THE DEVICE DOOR ROLLER WAS BROKEN. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109004 PLUM A+ DRIVER ED 2 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA PLUM A+ SOFTWARE MODULE: LIST #UNK, SN UNK