BEUDAMED
    FDA Adverse Event Death Summary report: N

    CENTRYSYSTEM 3

    MDR report key: 508606 · Received January 27, 2004

    Report

    Report Number
    508606
    Event Type
    Death
    Date Received
    January 27, 2004
    Date of Event
    January 15, 2004
    Report Date
    January 26, 2004
    Manufacturer
    GAMBRO HEALTH CARE
    Product Code
    FII
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING HEMODIALYSIS. AT LAST CHECK 20 MINUTES EARILIER, THE PATIENT WAS STABLE. THE PATIENT WAS FOUND TO HAVE VENOUS NEEDLE DISCONNECTED, WITH APPROX 250ML ESTIMATED BLOOD LOSS. THE VENOUS PRESSURE ALARM FAILED TO SOUND. THE PATIENT WAS UNRESPONSIVE, REQUIRED RESUSCITATION AND TRANSFER FROM DIALYSIS CENTER AND ADMISSION TO CRITICAL CARE UNIT. ANTERIOR WALL MYOCARDIAL INFARCTION WAS DOCUMENTED VIA EKG. THE PATIENT EXPIRED 2 DAYS LATER.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 3/22/04: IN 2004 GAMBRO TECHNICAL SERVICES (GTS) CONTACTED QA TO REPORT CLINIC REQUESTED MACHINE CHECKOUT. HE WAS NOTIFIED OF A PT THAT EXPIRED DUE TO A DISLODGED NEEDLE. PER A PHONE CONVERSATION WITH FACILITY DURING STAFF TURN OVER THE PT PULLED OUT THE NEEDLE AND LOST A LARGE AMOUNT OF BLOOD WHICH RESULTED IN THE PT SUFFERING CARDIAC ARREST. THE PT WAS INITIALLY RESUSCITATED BUT LATER EXPIRED. THE EXACT TIME OF DEATH IS UNKNOWN. THE DEVICE WAS BEING USED FOR PT TREATMENT AT THE TIME OF THE INCIDENT. PROCEDURAL FACTORS MAY HAVE CONTRIBUTED IN THAT INADEQUATELY SECURING THE VENOUS NEEDLE TO THE PT'S ACCESS SITE CAN RESULT IN THE NEEDLE BECOMING DISLODGED. IT IS NOT DEFINITELY KNOWN, HOWEVER, THAT THE NEEDLE WAS NOT ADEQUATELY SECURED. THE PREVENTATIVE MEASURE FOR THIS ISSUE IS TO SECURELY FASTEN THE NEEDLE TO THE TUBING SET LUER AND THE NEEDLE TO THE ARM OF THE PT BY TAPE OR OTHER MEASURES SO THAT RANDOM MOVEMENT BY THE PT DOES NOT DISLODGE THE NEEDLE OR CAUSE THE LUER LOCK TO LOOSEN. IN ADDITION, THE ALARM WINDOW CAN BE SET TIGHTER (AS SMALL AS +4/-4 MMHG). THE VENOUS PRESSURE LOW ALARM WINDOW CAN BE ADJUSTED SEPARATELY TO BE LIGHTER THAN 50 MMMHG. HOWEVER, AS THE WINDOW IS TIGHTENED, THE POTENTIAL FOR NUISANCE PRESSURE ALARMS WHICH INTERRUPT THE TREATMENT CORRESPONDINGLY INCREASES. AN ARTICLE WRITTEN BY GAMBRO CLINICAL SERVICES CONCERNING NEEDLE DISLODGEMENT WAS PROVIDED TO THE CLINIC FOR EDUCATION PURPOSES. FACILITY FUNCTIONALLY TESTED THE MACHINE AND FOUND IT TO BE OPERATING TO MFR'S SPECFICIATIONS. THE MACHINE WAS PLACED BACK INTO SERVICE WITHOUT COMPONENT CALIBRATION OR REPLACEMENT. BASED ON THE ABOVE, THERE IS NO INFO THAT REASONABLY SUGGESTS THE MACHINE CAUSED OR CONTRIBUTED TO THIS INCIDENT. SAFETY ANALYSIS: A SAFETY ANALYSIS IN THIS CASE IS NOT REQUIRED, AS NO MACHINE MALFUNCTION WAS IDENTIFIED. FOLLOW-UP ACTION: THIS ISSUE WILL CONTINUE TO BE TRENDED AS PART OF THE GAMBRO RENAL PRODUCTS' CORRECTIVE ACTION SYSTEM AND THE INTERNAL MGMT REVIEW TEAM. ANY FURTHER INVESTIGATIONS, ANALYSES, AND/OR CORRECTIVE ACTIONS TAKEN ON THIS COMPLAINT ISSUE WILL BE DETERMINED BY AND DOCUMENTED IN THE MGMT REVIEW PROCESS FOR CORRECTIVE AND PREVENTATIVE ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRYSYSTEM 3 HEMODIALYSIS MACHINE FII GAMBRO HEALTH CARE CENTRYSYSTEM 3 *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death| H| L| R