BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFECARE PCA 3 V5.06

    MDR report key: 2180853 · Received May 16, 2011

    Report

    Report Number
    9615050-2011-00356
    Event Type
    Death
    Date Received
    May 16, 2011
    Date of Event
    February 19, 2010
    Report Date
    April 19, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    MEA
    PMA / PMN Number
    K042800
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, IT IS UNK IF THE DEVICE WILL BE RETURNING FOR EVAL. IF THE DEVICE IS RECEIVED, A F/U REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    DOCUMENTS RECEIVED ALLEGE PT DEATH WHILE DEVICE WAS IN USE. THE DOCUMENT STATED ON (B)(6) 2010, THE PT WAS ADMITTED TO THE HOSPITAL FOR THE TREATMENT OF KIDNEY STONES. ON AN UNSPECIFIED DATE AND TIME, IT WAS ALLEGED THAT THE PT WAS CONNECTED TO ANOTHER MFR PUMP TO DELIVER UNSPECIFIED IV FLUIDS AND "WAS ALSO CONNECTED TO A 'LIFECARE MODEL' PT CONTROLLED ANESTHESIA (PCA) MACHINE" TO DELIVER UNSPECIFIED PAIN MEDICATION. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. AT UNSPECIFIED TIMES "THROUGHOUT THE DAY" ON (B)(6) 2010, A NURSE "STARTED VARIOUS BAGS OF IV FLUIDS AND IV PAIN MEDICATIONS." AT AN UNSPECIFIED TIME DURING THE AFTERNOON, A NURSE "STARTED A BAG OF IV FLUIDS." AT UNSPECIFIED TIMES DURING THE NIGHT, 2 BAGS OF UNSPECIFIED IV FLUIDS WERE STARTED. THE DOCUMENTS STATE ON (B)(6) 2010 AT APPROX 0145, "A NURSE PASSED BY (THE PT'S) HOSPITAL ROOM AND HEARD ONE OF HIS IV PUMPS BEEPING." UPON ENTERING THE HOSPITAL ROOM, THE NURSE FOUND THE PT "UNRESPONSIVE AND A CODE BLUE WAS CALLED." AT 0230, THE PT EXPIRED. THE AUTOPSY INDICATED THE CAUSE OF DEATH AS "150ML OF AIR IN (THE PT'S) HEART." NO ADDITIONAL INFO WAS PROVIDED. IT IS NOTED THAT THE HOSPIRA PCA PUMP REQUIRES USE OF COMPATIBLE VIALS THAT HAVE A MAXIMUM VOLUME OF 30ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFECARE PCA 3 V5.06 80MEA MEA HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death MANUFACTURED BY CAREFUSION| IMED PC1 VOLUMETRIC PUMP/CONTROLLER: MODEL #1310B