BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ DRIVER NEW 8

    MDR report key: 2110897 · Received April 5, 2011

    Report

    Report Number
    9615050-2011-00233
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    February 24, 2011
    Report Date
    March 7, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    USER FACILITY VOLUNTARY MEDWATCH RECEIVED THAT STATED: "PT WAS ON A HOSPIRA PLUM A+ PUMP WITH EPINEPHRINE INFUSING. THIS WAS THE ONLY MEDICATION THAT WAS INFUSING AT THE TIME. THE PUMP GAVE AUDIBLE ALARM AND SCREEN READ 'MALFUNCTION' AND PUMP STOPPED. PT'S BLOOD PRESSURE DROPPED TO PRECARIOUS LOW LEVELS. PUMP CHANGED, CHILD'S BLOOD PRESSURE BACK TO NORMAL RANGE." UPON FURTHER INQUIRY, THE CUSTOMER CONTACT REPORTED A DELAY IN CRITICAL THERAPY DURING AN ALARM CONDITION. AT AN UNSPECIFIED TIME, THE DEVICE WAS PROGRAMMED TO DELIVER EPINEPHRINE 16MG/4000ML AND THE DELIVERY WAS STARTED. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. THE PT'S BLOOD PRESSURE WAS REPORTED TO BE 88/50MMHG. AT 2008, THE DEVICE ALARMED WITH AN UNSPECIFIED MALFUNCTION ALARM. THE CUSTOMER CONTACT REPORTED THE PT'S BLOOD PRESSURE DECREASE TO AN UNSPECIFIED VALUE. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. AFTER AN UNSPECIFIED LENGTH OF TIME, THE PT'S BLOOD PRESSURE WAS REPORTED TO BE 85/47MMHG. IT WAS REPORTED THAT AT 2200, THE PT EXPIRED; HOWEVER, THE CUSTOMER CONTACT STATED, "THIS WAS NOT DUE TO THE DEVICE MALFUNCTION." THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED INCLUDING THE PT'S BLOOD PRESSURE DURING THE ALARM CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM A+ DRIVER NEW 8 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR SN (B)(4)| PLUM A+ SOFTWARE MODULE, LIST #20791,