BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUM XLM W/DATAPORT

    MDR report key: 1627908 · Received March 9, 2010

    Report

    Report Number
    2921482-2010-00118
    Event Type
    Injury
    Date Received
    March 9, 2010
    Date of Event
    February 7, 2010
    Report Date
    February 8, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K010924
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAD 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 THE DEVICE WAS FOUND DELIVERING AT A RATE DIFFERENT THAN THE ORIGINALLY PROGRAMMED RATE RESULTING IN THE PT RECEIVING MORE MEDICATION THAN INTENDED. THE PT WAS BEING TREATED FOR A DIAGNOSIS OF NON ST ELEVATION MI (MYOCARDIAL INFARCTION) IN THE EMERGENCY ROOM. AT 2153, THE DEVICE WAS PROGRAMMED TO DELIVER HEPARIN 25,000 UNITS/500ML AT A RATE OF 14 ML/HR AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AT 2257, THE DEVICE SOUNDED AN ALARM FOR AN UNSPECIFIED CONDITION. AT THIS TIME, THE NURSE NOTED THE "ENTIRE BAG OF HEPARIN WAS INFUSED AND THE DEVICE WAS RUNNING AT A RATE OF 500ML/HR." THE PHYSICIAN WAS NOTIFIED. REPORTEDLY AT 2320, THE PT WAS "RESTING COMFORTABLY WITH NO SHORTNESS OF BREATH OR COMPLAINTS OF CHEST PAIN; HOWEVER, AT 2340 THE PT WAS TREATED WITH AN UNSPECIFIED CONCENTRATION OF PROTAMINE SULFATE OF BREATH IVP. ON (B) (6) 2010 AT 0050, THE PT WAS TREATED WITH A SECOND UNSPECIFIED DOSE OF PROTAMINE SULFATE, IVP. AT 0112, A PTT (PARTIAL THROMBOPLASTIN TIME) WAS DRAWN WITH THE RESULTS REPORTED AS 14.3 SECONDS. AT 0418, ANOTHER PTT LEVEL WAS DRAWN WITH THE RESULTS REPORTED AS 111.8 SECONDS. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. AT 0722, THE PT WAS TRANSPORTED TO A TERTIARY CENTER, WHERE A BALLOON ANGIOPLASTY WAS PERFORMED. THE PT WAS DISCHARGED ON (B) (6) 2010 IN "STABLE CONDITION." INFO WAS REQUESTED FROM THE CUSTOMER CONTACT REGARDING CLARIFICATION OF THE PTT LEVELS, THE PT'S SYMPTOMS THAT NECESSITATED TWO DOSES OF PROTAMINE SULFATE, AND IF THE HEPARIN THERAPY WAS RESUMED WITH A REPLACEMENT DEVICE. THE CUSTOMER CONTACT COULD NOT PROVIDE THE REQUESTED INFO BUT INDICATED THAT THE USER THE FACILITY WILL CONTINUE TO INVESTIGATE. IF ADD'L PT OR EVENT INFO IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM XLM W/DATAPORT 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention HEPARIN, MANUFACTURER UNK