BEUDAMED
    FDA Adverse Event Death Summary report: N

    PCA II PUMP

    MDR report key: 2072273 · Received April 28, 2011

    Report

    Report Number
    6000001-2011-03267
    Event Type
    Death
    Date Received
    April 28, 2011
    Date of Event
    August 25, 2010
    Report Date
    April 6, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K902613
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN REQUESTED FOR EVALUATION. FOLLOW UP INFORMATION WILL BE SENT ONCE THE DEVICE HAS BEEN RECEIVED AND EVALUATED.

    Additional Manufacturer Narrative · 1

    (B)(4) - THE PUMP WAS RECEIVED WITH THE 60ML DRUG SYRINGE AFFIXED IN THE DEVICE WITH THE DRUG LABEL STILL INTACT FOR 0.8 MG/ML OF HYDROMORPHONE (DILAUDID) IN 0.9% SODIUM CHLORIDE. THE EVENT HISTORY WAS REVIEWED: ON "(B)(6) 1988", AN INFUSION RAN AT THE FOLLOWING SETTINGS: MODE: PCA+BASAL; CONCENTRATION: 0.40 MG/ML; PCA DOSE: 0.40 MG; DELAY: 10 MINUTES; BASAL RATE: 0.0 MG/HR; 1-HOUR LIMIT: 2.40 MG. IT WAS CONCLUDED THAT THE CONCENTRATION STATED ON THE SYRINGE LABEL, 0.8 MG/ML, DID NOT MATCH THE MED CONCENTRATION PROGRAMMED INTO THE PUMP, 0.4 MG/ML. IT WAS ALSO REPORTED THAT VERSED WAS BEING INFUSED ON (B)(6) 2010. THE DRUG INFUSION WAS CHANGED TO DILAUDID ON AN UNKNOWN DATE. THE PATIENT DIED ON (B)(6) 2010. DURING THE ACCURACY TEST, THE INFUSION WAS STARTED AT 8:21AM AND RAN UNTIL 2:33PM. 19 PCA DOSES WERE ADMINISTERED FOR A TOTAL OF 7.6MG OF THE DRUG DELIVERED. THE ACTUAL FLUID DELIVERED WAS 18.9ML OR A NEGATIVE 0.53% OF THE EXPECTED DELIVERY OF 19ML (ACCEPTABLE RANGE IS +/-3%). THE EVENT HISTORY REVIEW REVEALED THAT THE TIME AND DATE ON THE DEVICE AT THE TIME OF THE EVALUATION WAS "10:08 (B)(6) 1988" WHICH DID NOT CORRESPOND TO THE REAL DATE OF THE PRODUCT ANALYSIS LAB (PAL) EVALUATION OF 9:53AM (B)(6) 2011. THE YEAR 1988 IS THE DEFAULT YEAR FOLLOWING A POWER LOSS. THE PUMP PERFORMED AS DESIGNED DURING PAL TESTING. THERE WAS NO INDICATION OF ANY PUMP MALFUNCTION. THE SERVICE HISTORY REVIEW STATED THE DEVICE HAD NOT BEEN SERVICED PRIOR TO THIS EVENT NOR SENT FOR SERVICE FOR THIS REPORTED CONDITION. NO EXCEPTION, NONCONFORMANCE, OR REWORK OCCURRED DURING THE MANUFACTURING OF THIS SERIAL NUMBER. THE ENGINEERING QUALITY REVIEW STATES THAT THE DEVICE EVALUATION REVEALED THE CONCENTRATION OF THE DRUG STATED ON THE SYRINGE LABEL DID NOT MATCH THE CONCENTRATION PROGRAMMED INTO THE PUMP. THEREFORE, THE ROOT CAUSE OF THE REPORTED PATIENT DEATH WAS DETERMINED AS USE- USER ERROR. THE LABELING REVIEW AND CLINICAL RESPONSE STATED THAT IT COULD NOT BE SUBSTANTIATED WHICH OF THE DOSES OF DILAUDID WAS ACTUALLY PRESCRIBED, SO THE WORST CASE SCENARIO IS THAT THE MAXIMUM DOSE THE PATIENT RECEIVED WAS 13.6MG OVER 12HOURS 33 MINUTES WHICH IS BELOW THE MAXIMUM ALLOWABLE TIME FRAME. THE USER INSTRUCTIONS PROVIDED IN THE PCAII PUMP AND THE MULTI MODE CARTRIDGE OPERATOR'S MANUALS WERE SUFFICIENT IN PROVIDING THE USER WITH PROPER DIRECTIONS ON ASSURING THAT THE SYRINGE IS PROPERLY FILLED AND THE CORRECT PRESCRIPTION IS PROGRAMMED INTO THE PUMP. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    BAXTER RECEIVED A CALL FROM THE DIRECTOR OF THE U.S. ARMY CRIMINAL INVESTIGATION LAB. HE REQUESTED AN EVALUATION OF THE PCAII PUMP WHICH WAS BEING USED COINCIDENT WITH A PATIENT'S DEATH. HE DID NOT ALLEGE ANY RELATION OF THE DEVICE TO THE PATIENT'S DEATH. HE DID NOT REPORT OR ALLEGE ANY MALFUNCTION OF THE DEVICE. HE REPORTED THAT VERSED WAS BEING INFUSED ON (B)(6) 2010, THE INFUSION WAS SWITCHED TO DILAUDID ON (B)(6) 2010 AND THE PATIENT DIED ON (B)(6) 2010. IT WAS ALSO REPORTED THAT THE ARMY CRIME LAB IS CONDUCTING AN INVESTIGATION OF THEIR OWN. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA II PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O VERSED| DILAUDID