BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLMA DVC V11.51 1 R

    MDR report key: 2359601 · Received November 8, 2011

    Report

    Report Number
    9615050-2011-00867
    Event Type
    Malfunction
    Date Received
    November 8, 2011
    Date of Event
    October 1, 2011
    Report Date
    October 11, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. 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 LESS MEDICATION THAN INTENDED. ON AN UNSPECIFIED DATE AND TIME, LINE A WAS PROGRAMMED TO DELIVERY AN UNSPECIFIED IV SOLUTION. LINE B WAS PROGRAMMED IN THE PIGGYBACK MODE, TO DELIVER AN UNSPECIFIED MEDICATION, FOR A DURATION OF 2 HOURS. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AFTER APPROX 1 HOUR, THE CUSTOMER CONTACT REPORTED THE PUMP HAD "SWITCHED FROM LINE B TO LINE A." THE CUSTOMER CONTACT REPORTED THE PUMP WAS NOT PROGRAMMED TO SWITCH TO LINE A AFTER THE DELIVERY ON LINE B COMPLETED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. MULTIPLE UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLMA DVC V11.51 1 R 89FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK (B)(6)| PLUM A+ SOFTWARE MODULE LIST #12097