BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM A+ PLATINUM MODU

    MDR report key: 2093349 · Received April 15, 2011

    Report

    Report Number
    9615050-2011-00260
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    December 26, 2010
    Report Date
    March 17, 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
    CT, US
    Reporter Occupation
    RISK MANAGER

    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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE PATIENT RECEIVED MORE MEDICATION THAN INTENDED. ON AN UNSPECIFIED DATE AND TIME, LINE A OF THE DEVICE WAS PROGRAMMED TO DELIVER 2000ML OF TOTAL PARENTERAL NUTRITION (TPN), AT A RATE OF 83ML/HR, AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. ON (B)(6) 2010 AT 2300, THE CLINICIAN NOTED THAT THERE WAS APPROXIMATELY 500ML REMAINING IN THE TPN CONTAINER. AT 0400, THE CLINICIAN NOTED THAT THE TPN CONTAINER WAS EMPTY. THE PHARMACY WAS NOTIFIED AND INFORMED THE CLINICIAN THAT THE TPN SHOULD HAVE LASTED FOR AN UNSPECIFIED LENGTH OF TIME LONGER THAN IT DID. IT WAS REPORTED THAT ACCORDING TO THE HOSPITAL POLICY, WHILE WAITING FOR ANOTHER CONTAINER OF TPN TO BE SENT FROM PHARMACY, THE DEVICE WAS PROGRAMMED TO DELIVER 10% DEXTROSE, AT A RATE OF 83ML/HR, AND THE DELIVERY WAS STARTED. REPORTEDLY, BETWEEN 0900 AND 1000, THE CLINICIAN NOTED THE DEVICE "APPEARED" TO DELIVER AT A RATE OF 120ML/HR INSTEAD OF THE PROGRAMMED RATE OF 83ML/HR. THE PHYSICIAN WAS NOTIFIED AND A CHEMISTRY PANEL WAS DRAWN. THE RESULTS WERE REPORTED AS "NORMAL." THERE WERE NO ADVERSE PATIENT EFFECTS. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. NO MEDICAL INTERVENTIONS WERE REQUIRED. DURING TESTING AT THE USER FACILITY, THE DEVICE PASSED TESTING. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLM A+ PLATINUM MODU 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR PLUM A+ SOFTWARE MODULE: LIST # 12097,| SN (B)(4)