BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM XLM W/MODIFD B

    MDR report key: 2092943 · Received April 20, 2011

    Report

    Report Number
    9615050-2011-00275
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010924
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR EVAL. IF THE DEVICE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. 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 DEVICE WAS FOUND DELIVERING AT A RATE DIFFERENT THAN ORIGINALLY PROGRAMMED RATE, RESULTING IN THE PT RECEIVING MORE MEDICATION THAN INTENDED. DURING A CARDIAC STRESS TEST, THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF DOBUTAMINE, AT A RATE OF 64ML/HR, AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AFTER APPROX 2 1/2 MINUTES, THE PT'S HEART RATE (HR) INCREASED FROM A RESTING HEART RATE OF 86 BPM (BEATS PER MINUTE) TO 118 BPM. AT THIS TIME, THE NURSE NOTED THAT THE DEVICE DISPLAYED A RATE OF 158ML/HR. THE DEVICE WAS POWERED OFF AND THE PROCEDURE WAS STOPPED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE PT'S HEART RATE DECREASED TO 109 BPM. NO MEDICAL INTERVENTIONS WERE REQUIRED. AT THIS TIME, THE DEVICE WAS REPROGRAMMED TO DELIVER AT AN UNSPECIFIED RATE AND THE STRESS TEST WAS COMPLETED. THE CUSTOMER CONTACT INDICATED THAT THE TARGET HEART RATE FOR THE PT DURING THE STRESS TARGET HEART RATE FOR THE PT DURING THE STRESS TEST WAS 138 BPM; HOWEVER, THE CLINICIAN WOULD HAVE BEEN "GRADUALLY INCREASING THE DOBUTAMINE EVERY 3 MINUTES TO INCREASE THE HEART RATE ANYWAY." THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM XLM W/MODIFD B 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR