BEUDAMED
    FDA Adverse Event Death Summary report: N

    PLUM A+ PUMP

    MDR report key: 1030761 · Received April 17, 2008

    Report

    Report Number
    2921482-2008-00127
    Event Type
    Death
    Date Received
    April 17, 2008
    Date of Event
    March 9, 2008
    Report Date
    March 12, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K011442
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PASSED TESTING FOR DELIVERY ACCURACY. THE DEVICE HISTORY WAS DOWNLOADED AT THE SVC CTR. ON (B)(6) 2008 AT 0048, "NO" WAS SELECTED AT THE CLEAR SETTINGS PROMPT. AT 0051, THE PUMP ALARMED FOUR TIMES FOR PROXIMAL OCCLUSION LINE B. AT 0052, "NO" WAS SELECTED AT THE CLEAR SETTINGS PROMPT. WITHIN THE SAME MINUTE, LINE A WAS PROGRAMMED TO DELIVER AT A RATE OF 117ML/HR WITH A VTBI (VOLUME TO BE INFUSED) OF 468ML FOR A DURATION OF 4 HRS AND THE DELIVERY WAS STARTED. AT 0113, THE PUMP ALARMED FOR PROXIMAL AIR A, BACKPRIME, AND AT 0114 THE PUMP WAS POWERED OFF. AT 0116, THE PUMP WAS POWERED ON. WITHIN THE SAME MINUTE THE DEVICE ALARMED CASSETTE TEST FAILURE. AT 0117, THE DELIVERY WAS RESTARTED WITH THE SAME PROGRAMMING PARAMETERS. WITHIN THE SAME MINUTE, THE DELIVERY WAS STOPPED WITH A TOTAL VOLUME INFUSED OF 73.4 ML. AT 0118, THE PUMP WAS PROGRAMMED IN THE ML/HR MODE TO DELIVER AT A RATE OF 2.3 ML/HR WITH A VTBI OF 427.7ML FOR A DURATION OF 185 HRS AND 57 MINS, AND THE DELIVERY WAS STARTED. AT 0135, THE DELIVERY WAS STOPPED, AND THE PUMP WAS POWERED OFF. REVIEW OF THE HISTORY INDICATES THE PUMP DELIVERED AS PROGRAMMED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE PASSED TESTING FOR DELIVERY ACCURACY. THE DEVICE HISTORY WAS DOWNLOADED AT THE SVC CTR. IN 2008 AT 0048, "NO" WAS SELECTED AT THE CLEAR SETTINGS PROMPT. AT 0051, THE PUMP ALARMED FOUR TIMES FOR PROXIMAL OCCLUSION LINE B. AT 0052, "NO" WAS SELECTED AT THE CLEAR SETTINGS PROMPT. WITHIN THE SAME MINUTE, LINE A WAS PROGRAMMED TO DELIVER AT A RATE OF 117ML/HR WITH A VTBI (VOLUME TO BE INFUSED) OF 468ML FOR A DURATION OF 4 HRS AND THE DELIVERY WAS STARTED. AT 0113, THE PUMP ALARMED FOR PROXIMAL AIR A, BACKPRIME, AND AT 0114 THE PUMP WAS POWERED OFF. AT 0116, THE PUMP WAS POWERED ON. WITHIN THE SAME MINUTE THE DEVICE ALARMED CASSETTE TEST FAILURE. AT 0117, THE DELIVERY WAS RESTARTED WITH THE SAME PROGRAMMING PARAMETERS. WITHIN THE SAME MINUTE, THE DELIVERY WAS STOPPED WITH A TOTAL VOLUME INFUSED OF 73.4 ML. AT 0118, THE PUMP WAS PROGRAMMED IN THE ML/HR MODE TO DELIVER AT A RATE OF 2.3 ML/HR WITH A VTBI OF 427.7ML FOR A DURATION OF 185 HRS AND 57 MINS, AND THE DELIVERY WAS STARTED. AT 0135, THE DELIVERY WAS STOPPED, AND THE PUMP WAS POWERED OFF. REVIEW OF THE HISTORY INDICATES THE PUMP DELIVERED AS PROGRAMMED. 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 PT RECEIVED MORE MEDICATION THAN INTENDED. ON (B)(6) 2008 AT 1600, THE PUMP WAS PROGRAMMED TO DELIVER TOTAL PARENTERAL NUTRITION AT A RATE OF 2.3 ML/HR WITH A VOLUME TO BE INFUSED OF 63ML AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. ON (B)(6) 2008 AT APPROX 0050, IT WAS REPORTED THAT THE DEVICE ALARMED FOR AN UNSPECIFIED ALARM CONDITION. AT 0125, THE DEVICE REPORTEDLY DISPLAYED A TOTAL VOLUME INFUSED OF 73.3 ML. ON AN UNSPECIFIED DATE AND TIME, THE "PT DIED". THE DEVICE WAS REMOVED FROM CLINICAL SVC. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE PT RECEIVED MORE MEDICATION THAN INTENDED. IN 2008 AT 1600, THE PUMP WAS PROGRAMMED TO DELIVER TOTAL PARENTERAL NUTRITION AT A RATE OF 2.3 ML/HR WITH A VOLUME TO BE INFUSED OF 63ML AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. THE NEXT DAY AT APPROX 0050, IT WAS REPORTED THAT THE DEVICE ALARMED FOR AN UNSPECIFIED ALARM CONDITION. AT 0125, THE DEVICE REPORTEDLY DISPLAYED A TOTAL VOLUME INFUSED OF 73.3 ML. ON AN UNSPECIFIED DATE AND TIME, THE "PT DIED". THE DEVICE WAS REMOVED FROM CLINICAL SVC. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DA Death TOTAL PARENTERAL NUTRITION, MFR UNK| PLUM A+ SOFTWARE MODULE, LIST# 12097, SN (B)(4)