BEUDAMED
    FDA Adverse Event Death Summary report: N

    PLUM A+ DRIVER ED 2

    MDR report key: 3070685 · Received April 15, 2013

    Report

    Report Number
    9615050-2013-00722
    Event Type
    Death
    Date Received
    April 15, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 19, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE DEVICE HISTORY WAS DOWNLOADED AT THE SERVICE CENTER. A REVIEW OF THE HISTORY INDICATES ON (B)(6) 2013 AT 1337 THE DEVICE WAS TURNED ON, THE SETTINGS WERE CLEARED, THE DOOR WAS CLOSED, AND THE DEVICE ALARMED FOR N185 (PROX OCCL A AT STARTUP). AT 1446, THE DEVICE ALARMED FOR N101 (NO ACTION ALARM). AT 1449, THE DOOR WAS CLOSED AND THE DEVICE ALARMED N185. AT 1450, PROGRAMMING WAS CANCELED, THE DEVICE ALARMED N185 ONCE, N183 (PROX OCCL B AT STARTUP) 3 TIMES, AND WAS BACKPRIMED 3 TIMES. AT 1451, THE DEVICE WAS TURNED OFF. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A DELAY OF CRITICAL THERAPY FOLLOWING AN ALARM CONDITION. AT AN UNSPECIFIED TIME, THE PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT IN RESPIRATORY ARREST. IT WAS REPORTED THAT DURING SETUP PRIOR TO PATIENT USE, THE DEVICE ALARMED FOR PROXIMAL AIR. AT THAT TIME, THE NURSE WAS UNABLE TO CLEAR THE ALARM. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. IT WAS REPORTED THAT 3 TO 5 MINUTES LATER, A REPLACEMENT DEVICE WAS OBTAINED. THE DEVICE WAS PROGRAMMED TO DELIVER DOPAMINE 1 MG/1 KG AND THE DELIVERY WAS STARTED. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. THE CUSTOMER CONTACT REPORTED THAT AFTER AN UNSPECIFIED LENGTH OF TIME, THE PATIENT WAS STABILIZED; HOWEVER, THE PATIENT REMAINED IN CRITICAL CONDITION. ON (B)(6) 2013 AT 2230, IT WAS REPORTED THE PATIENT EXPIRED. IT WAS REPORTED THE CAUSE OF DEATH WAS A HEART ATTACK. NO AUTOPSY WAS PERFORMED. THE CUSTOMER CONTACT REPORTED THE DEVICE DID NOT CONTRIBUTE TO THE PATIENT'S DEATH. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161556 PLUM A+ DRIVER ED 2 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Death DOPAMINE: MANUFACTURER UNK| PLUMSET: LIST #UNK, LOT #UNK| PLUM A+ SOFTWARE MODULE: LIST #20791| SN (B)(4)