BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM SITE CHBR W/BALL PP YSTE 264CM NDHP

    MDR report key: 2701869 · Received August 14, 2012

    Report

    Report Number
    9615050-2012-00931
    Event Type
    Malfunction
    Date Received
    August 14, 2012
    Date of Event
    July 1, 2012
    Report Date
    July 16, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. DURING THE INVESTIGATION, NO POSSIBLE CAUSES FOR THE CUSTOMER REPORTED PTS RECEIVED LESS MEDICATION THAN INTENDED WERE IDENTIFIED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER, HAS A COMMON DEVICE NAME OF 80FPA AND HAS A 510K OF K101677. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF THE PTS RECEIVED LESS MEDICATION THEN INTENDED. THE TUBING SETS WERE BEING USED TO DELIVER UNSPECIFIED MEDICATIONS, AT RATES OF 900 ML/HR, FOR DURATION OF ONE HOUR, VIA UNSPECIFIED PLUM PUMPS. THE CUSTOMER CONTACT REPORTED THAT THE DRIP CHAMBERS OF THE TUBING SETS WERE 3/4 FULL OF SOLUTION. AFTER UNSPECIFIED LENGTHS OF TIME, THE CUSTOMER CONTACT REPORTED THE PUMPS ALARMED FOR PROXIMAL OCCLUSION. IT WAS REPORTED THAT THE BALL IN THE DRIP CHAMBERS WERE OCCLUDING THE DISTAL END OF THE DRIP CHAMBERS. THE CUSTOMER CONTACT REPORTED THAT FOR AN UNSPECIFIED NUMBER OF INCIDENTS, THE TUBING SETS WERE REPLACED AND THE THERAPIES WERE RESUMED. IT WAS REPORTED THAT THE MEDICATION DELIVERIES WERE COMPLETE IN TWO HOURS INSTEAD OF THE INTENDED ONE HOUR. IT WAS REPORTED THAT THERE WERE DELAYS IN THERAPIES CRITICAL TO AN UNSPECIFIED NUMBER OF PTS; HOWEVER, THERE WERE NO ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM SITE CHBR W/BALL PP YSTE 264CM NDHP UNK FPA HOSPIRA COSTA RICA LTD. NA 143605H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PLUM PUMPS: LIST NUMBER UNK, SN UNK