BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS SE PUMP

    MDR report key: 2384429 · Received December 14, 2011

    Report

    Report Number
    2016493-2011-00641
    Event Type
    Death
    Date Received
    December 14, 2011
    Date of Event
    November 15, 2011
    Report Date
    November 18, 2011
    Manufacturer
    CAREFUSION CORP
    Product Code
    FRN
    PMA / PMN Number
    K931549
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS INCONCLUSIVE AS THE CUSTOMER'S FEEDBACK COULD NOT BE CONFIRMED. PRODUCT TESTING AND AN EVENT LOG REVIEW DID NOT IDENTIFY OR SHOW ANY DEFICIENCIES WITH THE PUMP OR INFUSION SET THAT WOULD HAVE RESULTED IN A FREE FLOW CONDITION. BOTH THE INFUSION PUMP AND THE INFUSION SET IN USE AT THE TIME OF THE EVENT WERE RETURNED FOR INVESTIGATION. THE RETURNED INFUSION SET WAS RECEIVED ATTACHED TO AN EMPTY 250 ML BAG OF 5% GLUCOSE WITH 20 MG NORADRENALINE. THE ACCUSLIDE CLAMP WAS CLOSED. THE MALE LUER AT THE DISTAL END OF THE SET WAS RETURNED CONNECTED TO A THREE WAY TAP WHICH WAS ALSO CLOSED. A VISUAL INSP IDENTIFIED DAMAGE TO THE OUTER SURFACE OF THE MALE LUER WHICH APPEARED TO BE CONSISTENT WITH THE USER OF FORCEPS IN ORDER TO REMOVE THE LUER FROM ANOTHER DEVICE. TESTING DID NOT IDENTIFY ANY OTHER DEFECTS OR LEAKAGES AND CONFIRMED THE CORRECT OPERATION OF THE ACCUSLIDE CLAMP. A VISUAL INSP OF THE PUMP (EXTERNAL AND INTERNAL) DID NOT IDENTIFY ANY DEFECTS. FUNCTIONAL TESTING CONFIRMED THAT THE PUMP WAS OPERATING WITHIN SPEC. A REVIEW OF THE EVENT LOG CONFIRMED THAT A NORADRENALINE INFUSION WAS PROGRAMMED AND COMMENCED ON (B)(6) 2011 AT 14:17 WITH THE RATE SET TO 2 ML/HOUR (0.0444 MCG/KG/MINUTE) AND THE VTBI SET TO 200 ML. THE RATE WAS ADJUSTED BY THE USER AT VARIOUS STAGES DURING THE INFUSION WITH RATES BETWEEN 1 ML/HOUR AND 4 ML/HOUR. THE PUMP WAS INFUSING AS PROGRAMMED BY THE USER AT THE REPORTED INCIDENT TIME OF (B)(6) 2011 AT 16:00. AT THE SECOND REPORTED INCIDENT TIME OF 6:11 ON (B)(6) 2011, THE PUMP WAS INFUSION AT 1.0 ML/HOUR, HOWEVER AT 6:33 THE INFUSION WAS PLACED "ON HOLD" BY THE USER AND TWO MINUTES LATER AT 6:35 THE PUMP WAS POWERED "OFF." THE PUMP WAS THEN REPOWERED ON AT 7:05 AND THE NORADRENALINE INFUSION RESUMED AT A RATE OF 1 ML/HR. THE INFUSION WAS THEN DISCONTINUED AND THE PUMP POWERED OFF BY THE USER AT 10:47 (FOLLOWING RATE ADJUSTMENTS BETWEEN 1 ML/HOUR AND 2 ML/HOUR). THE EVENT LOG REVIEW DEMONSTRATED AT NO TIME DURING THE USE OF THE PUMP WAS THE INFUSION SET REMOVED FROM THE PUMPING MECHANISM, AS THIS WOULD HAVE BEEN RECORDED IN THE EVENT LOG. REMOVAL OF THE INFUSION SET REQUIRES THE LATCH TO BE OPENED, AN ACTION THAT AUTOMATICALLY CLAMPS THE SET PRIOR TO THE SET BEING EJECTED FROM THE PUMP, THEREFORE PREVENTING FREE FLOW. TESTING CONFIRMED THAT AN INFUSION SET COULD ONLY BE REMOVED BY THE USER OPENING THE LATCH AND ALSO CONFIRMED THE ENGAGEMENT OF THE CLAMP DURING THIS ACTION. IT IS POSSIBLE THAT THE SET WAS REMOVED FROM THE PUMP DURING THE 6:35 TO 7:05 PERIOD WHEN THE PUMP WAS POWERED OFF, ALTHOUGH THIS ACTION WOULD NOT BE LOGGED, REMOVING THE SET WOULD STILL REQUIRE THE USER TO OPEN THE LATCH WHICH WOULD AUTOMATICALLY CLAMP THE SET AS CONFIRMED BY THIS INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN OVER INFUSION OF NORADRENALINE. ADD'L DETAILS INDICATED THAT THE PT DEVELOPED BROAD TACHYCARDIA HR 177 AND RECEIVED SYNCHRONISED CONVERSION. WHEN THE CLINICIAN INSERTED A NEW ARTERIAL LINE AS THE CURRENT ONE WAS POSITIONAL, THEY NOTICED A 250 ML BAG WITH 20 MG NORADRENALINE HAD FREE FLOWED INTO THE PT. THE REPORT SUGGESTS THAT THE PUMP HAD EJECTED THE SET WITHOUT USER INTERVENTION AND THAT THE ACCUSLIDE CLAMP WAS IN AN OPEN POSITION AND THE THREE WAY TAP WAS ALSO OPEN. ALLEGEDLY THE FLUID BAG WAS FOUND ON THE FLOOR. THE DATE AND TIME OF THE INCIDENT WAS NOT CONFIRMED AS TWO DIFFERENT TIMES WERE REPORTED, (B)(6) 2011 AT 16:00 AND (B)(6) 2011 AT 06:11. THE INITIAL REPORT STATED THAT THERE WAS NO PT HARM HOWEVER IT WAS LATER REPORTED AT THE TIME OF THE EVENT THE PT HAD SUFFERED A CARDIAC ARREST FOLLOWING WHICH THEY WERE IN AN UNSTABLE CONDITION. FURTHER INFO WAS THEN RECEIVED STATING THAT THE PT HAD DIED AT A TIME FOLLOWING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SE PUMP FRN CAREFUSION CORP 7131 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death THREE WAY TAP: MODEL/LOT UNK| THERAPY DATE: (B)(6) 2011| THERAPY DATE: (B)(6) 2011| 250 ML BAG OF 5% GLUCOSE WITH 20MG NORADRENALINE:| ALARIS SE PRIMARY INFUSION SET:| MODEL 72303/LOT UNK| MODEL/LOT UNK, THERAPY DATE: (B)(6) 2011