BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCA PLUS 2 NEW

    MDR report key: 2172176 · Received June 15, 2011

    Report

    Report Number
    9615050-2011-00437
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 19, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K912928
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE PCA PLUS II PUMP, LIST# (B)(4), WITH 2.01 SOFTWARE VERSION DOES NOT CONTAIN A PUMP HISTORY THAT PROVIDES PAST PROGRAMMING SETTINGS. 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 PT RECEIVED MORE MEDICATION THAN INTENDED. ON AN UNSPECIFIED DATE AND TIME, THE PUMP WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF MORPHINE. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. THE CUSTOMER CONTACT REPORTED THAT AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE NURSE REPORTEDLY COULD NOT ACCOUNT FOR 10MG OF MEDICATION. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. MULTIPLE UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFO INCLUDING SPECIFIC PATIENT INFO, PUMP PROGRAMMING AND EVENT DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA PLUS 2 NEW 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK