BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ 3 MEDNET SW

    MDR report key: 2152682 · Received June 24, 2011

    Report

    Report Number
    9615050-2011-00452
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 27, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT CHANNEL 1 OF THE DEVICE WAS ABLE TO BE PROGRAMMED WHILE THE LOCKOUT SWITCH WAS IN THE LOCKED POSITION. THE DEVICE WAS RETURNED TO THE BIOMEDICAL ENGINEERING DEPARTMENT WITH A REPORT THAT THE DEVICE WAS ALARMING WITH N187 ((NEG DISTAL DELIVERY). NO SPECIFIC PATIENT INFORMATION, PUMP PROGRAMMING, OR EVENT DETAIL WERE PROVIDED. DURING TESTING AT THE USER FACILITY, CHANNEL 1 OF THE DEVICE WAS ABLE TO BE PROGRAMMED WHILE THE LOCKOUT SWITCH WAS IN THE LOCKED POSITION. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM A+ 3 MEDNET SW 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK