BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNDEO PCA SYRINGE PUMP

    MDR report key: 797530 · Received December 6, 2006

    Report

    Report Number
    6000001-2006-42870
    Event Type
    Injury
    Date Received
    December 6, 2006
    Date of Event
    November 7, 2006
    Report Date
    November 10, 2006
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    MEA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: EVALUATION WAS COMPLETED DURING ON SITE VISIT ON 11/27/06. FLOW ACCURACY TESTS WERE PERFORMED USING STANDARD PROCEDURE FLOW RATES AND THE CUSTOMER'S REPORTED RATE. THE PUMP WAS FOUND TO BE WITHIN SPECIFICATIONS. OPERATIONAL TESTS WERE PERFORMED AND THE DEVICE FUNCTIONED PROPERLY. NO PHYSICAL DAMAGES WERE FOUND UPON INTERNAL INSPECTION OF THE DEVICE. THIS INCIDENT HAS BEEN COMMUNICATED TO THE RESPONSIBLE BAXTER PERSONNEL TO REVIEW AND DETERMINE IF THIS DATA IS WITHIN THE EXPECTED LEVEL OF OCCURRENCE.

    Description of Event or Problem · 1

    BIOMED REPORTED A PATIENT DIED WHILE ON A SYNDEO PCA PUMP. PATIENT UNDERWENT A RIGHT TOTAL KNEE REPLACEMENT IN 2006. THE PATIENT WAS PRESCRIBED MORPHINE SULFATE (LOT MC2076 EXP 03/08, CONCENTRATION 1 MG/DL; PCA TUBING 2L3509 UNK LOT). THE ORDER CALLED FOR PCA ONLY, 1MG WITH A 10-MINUTE LOCKOUT. THE PUMP WAS PROGRAMMED WITH A 6MG LIMIT PER HOUR. THE INFUSION WAS STARTED IN THE PACU. ACCORDING TO NURSING NOTES THE FAMILY STATED THEY WERE PUSHING THE PCA BUTTON SO THAT THE PATIENT WOULDN'T BE IN ANY PAIN UPON WAKING UP. AT 2200 ON THE EVENT DATE, THE PATIENT'S BLOOD PRESSURE WAS 152/127. LATER ON AT 0000, THE PATIENT'S BLOOD PRESSURE WAS NOTED TO BE 93/43. THE PATIENT WAS CHECKED AGAIN BETWEEN 0230-0300 AS THE PUMP WAS BEEPING. AROUND 0430, THE CERTIFIED NURSE AIDE ENTERED THE PATIENT'S ROOM AND THE PATIENT WAS NONRESPONSIVE. A CODE WAS CALLED. THE FOLLOWING MEDICATIONS WERE GIVEN TO THE PATIENT DURING THE CODE: EPINEPHRINE 1MG X 3, ATROPINE 1MG X 1, ATROPINE 0.5MF X 4, D50 25G X 1, AMIODARONE 150MG THE N PLACED ON A DRIP, DOPAMINE 10MCG/KG DRIP, MAGNESIUM 1G X 1, NARCAN 0.4MG X 2, SALINE BOLUS X 3, DOBUTAMINE 5 MCG/KG DRIP. THE PATIENT EXPERIENCED A SEIZURE DURING THE CODE AND WAS GIVEN VALIUM X 2 AND SODIUM BICARBONATE 50 MEQ X 2. AT 0435, THE PATIENT WAS ORALLY INTUBATED WITH A 7.5 FR TUBE AND PLACED ON MECHANICAL VENTILATION. THE USED SYRINGE WAS REMOVED FROM THE PUMP WITH 28ML REMAINING. THE FOLLOWING RHYTHMS WERE NOTED DURING THE CODE: 0432-0437 ASYSTOLE, 0442 ATRIAL FIBRILLATION, 0457 AGONAL WITH PVCS, 0502 ATRIAL FIBRILLATION WITH PVCS, 0507 SINUS WITH OCCASIONAL PVCS, AND 0514 SINUS. THE PATIENT WAS TRANSFERRED TO THE ICU. THE PATIENT WAS STARTED ON LEVOPHED WHILE IN THE ICU. AT 0725, A CVP LINE WAS PLACED AT 1000 AN NG TUBE WAS PLACED, AND AT 1240 A LEFT SUBCLAVIAN TRIPLE LUMEN CENTRAL LINE WAS PLACED. AT 1000, THE PATIENT'S TEMPERATURE WAS NOTED TO BE 92.7 AND THE PATIENT WAS PLACED IN A BEAR HUGGER, AT 1400 THE TEMPERATURE WAS 99.7 AND THE BEAR HUGGER WAS REMOVED. LEVOPHED AND DOBUTAMINE WERE DISCONTINUED AT 1240. AT 1503, THE PATIENT WAS STARTED ON DILANTIN FOR SEIZURE ACTIVITY. DOPAMINE WAS DISCONTINUED AT 1825. THE PATIENT'S CODE STATUS WAS CHANGED TO DNR AT 1015 IN THE NEXT DAY. THE PATIENT EXPIRED AT 1926. PRELIMINARY CAUSED OF DEATH WAS APNEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNDEO PCA SYRINGE PUMP ANESTHESIA PUMPS MEA BAXTER HEALTHCARE (SG) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death