BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLM A+ PLATINUM MODU

    MDR report key: 1593797 · Received February 2, 2010

    Report

    Report Number
    2921482-2010-00037
    Event Type
    Injury
    Date Received
    February 2, 2010
    Date of Event
    December 27, 2009
    Report Date
    January 4, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED UNRESTRICTED FLOW. THE PT WAS BEING TREATED FOR AN UNSPECIFIED CARDIAC CONDITION. AT 1315, THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF HEPARIN, WITH A DOSE OF 700 UNITS/HR, AT A RATE OF 14ML/HR, A VTBI (VOLUME TO BE INFUSED) OF 400 ML, AND THE DELIVERY WAS STARTED. AFTER 1 HOUR AND 45 MINUTES, THE NURSE NOTED THAT APPROXIMATELY 100ML OF SOLUTION REMAINED IN THE SOLUTION CONTAINER AND THE DELIVERY WAS STOPPED. IT WAS REPORTED THE NURSE DISCONNECTED THE TUBING SET FROM THE PT, WITH THE DOOR IN THE CLOSED POSITION, AND UNRESTRICTED FLOW WAS NOTED FROM THE DISTAL END OF THE TUBING. THE PHYSICIAN WAS NOTIFIED. A PTT (PARTIAL THROMBOPLASTIN TIME) LEVEL DRAWN AND THE RESULTS WERE REPORTED AS 240 SECONDS AND THE CUSTOMER CONTACT REPORTED THE PT EXPERIENCED A LARGE HEMATOMA AROUND THE IV SITE. THE PT WAS TREATED WITH 50MG OF PROTOMINE SULFATE. THE CUSTOMER CONTACT STATED THAT THE PT "RECOVERED" AND THAT THERE WERE NO KNOWN LONG TERM EFFECTS. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. DURING TESTING AT THE USER FACILITY OF THE DEVICE WITH THE USED TUBING SET, NO UNRESTRICTED FLOW WAS NOTED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED INCLUDING IF THE DEVICE WAS REPLACED AND THE THERAPY WAS RESUMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Life Threatening| R PLUM A+ SOFTWARE MODULE, LIST#12680, (B) (4)| HEPARIN, MANUFACTURED BY HOSPIRA, INC.| PLUMSET, LIST #UNK, LOT # UNK