BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ TRIPLE NEW 8

    MDR report key: 3915207 · Received May 16, 2014

    Report

    Report Number
    9615050-2014-03471
    Event Type
    Malfunction
    Date Received
    May 16, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 11, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    Z-0625-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THAT THE CHANNEL 2 DEVICE DOOR ROLLER WAS MISSING AND THE DOOR ROLLER PIN WAS BROKEN. FURTHER TESTING, FOUND THAT CHANNEL 2 OF THE DEVICE HAD UNRESTRICTED FLOW AFTER THE DOOR WAS OPENED. THIS WAS DUE TO THE MISSING DOOR ROLLER AND BROKEN DOOR ROLLER PIN PREVENTED PROPER ACTUATION OF THE REGULATOR CLOSER ON THE DEVICE MECHANISM CAUSING UNRESTRICTED FLOW WHEN THE DEVICE 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 DEVICE WAS RETURNED TO THE SERVICE CENTER FOR A REPORT FROM THE CUSTOMER CONTACT THAT KEYPAD #2 WAS DAMAGED. THIS IS NOT A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CENTER, IT WAS NOTED THAT THE CHANNEL 2 DEVICE DOOR ROLLER WAS MISSING AND THE DOOR ROLLER PIN WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293966 PLUM A+ TRIPLE NEW 8 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA