BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ TRIPLE REFUR

    MDR report key: 3823359 · Received March 20, 2014

    Report

    Report Number
    9615050-2014-02193
    Event Type
    Malfunction
    Date Received
    March 20, 2014
    Date of Event
    February 23, 2014
    Report Date
    February 28, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMAITON KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    REPORT 1 OF 2. THE CUSTOMER CONTACT REPORTED A DELAY OF CRITICAL THERAPY DURING A REPORTED MALFUNCTION. IT WAS REPORTED, THAT THE PATIENT WS ADMITTED TO THE INTENSIVE CARE UNIT AND WAS POSSIBLY SEPTIC. AT AN UNSPECIFIED TIME, THE PATIENT WENT INTO CARDIAC ARREST. IT WAS REPORTED, THAT THE NURSE ATTEMPTED TO START LEVOPHED 2 MCG/KG ON THE DEVICE. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. IT WAS REPORTED, THAT THE DEVICE IMMEDIATELY ALARMED FOR "MALFUNCTION" UNSPECIFIED ERROR CODE DISPLAYED. THE CUSTOMER CONTACT REPORTED, THAT AFTER 1-2 MINUTES AFTER THE MALFUNCTION, THE PATIENT CODED. NO SPECIFIC EVENT DETAILS WERE PROVIDED. THE NURSE REMOVED THE TUBING SET FROM THE FIRST DEVICE AND INSERTED THE TUBING INTO THE SECOND DEVICE. THE SECOND DEVICE IMMEDIATELY ALARMED FOR "MALFUNCTION." IT WAS REPORTED, A FEW MINUTES AFTER THE SECOND MALFUNCTION, THE PATIENT CODED AGAIN. NO SPECIFIC EVENT DETAILS WERE PROVIDED. THE CUSTOMER CONTACT REPORTED AFTER AN UNSPECIFIED LENGTH OF TIME THE PATIENT EXPIRED. IT WAS REPORTED, THAT IT WAS UNSPECIFIED IF THE LEVOPHED THERAPY WAS INFUSING PRIOR TO THE CARDIAC ARREST, OR IF IT WAS EVER INITIATED. THE CAUSE OF DEATH IS UNKNOWN. IT IS UNKNOWN IF THE AUTOPSY WAS PERFORMED. MULTIPLE UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167745 PLUM A+ TRIPLE REFUR 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70S LEVOPHED, MANUFACTURER UNK| PLUMSET, LIST #UNK, LOT #UNK