BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRUM

    MDR report key: 766219 · Received September 29, 2006

    Report

    Report Number
    2221819-2006-00068
    Event Type
    Death
    Date Received
    September 29, 2006
    Date of Event
    July 24, 2006
    Report Date
    July 28, 2006
    Manufacturer
    DATASCOPE CORP.
    Product Code
    MHX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ON APRIL 3RD, THE JOINT COMMISSION ON ACCREDITATION OF HEALTHCARE ORGANIZATIONS ISSUED A SENTINEL EVENT ALERT ON THE DANGERS OF TUBING AND CATHETER MISCONNECTIONS. THE ARTICLE REPORTS THAT "MISCONNECTION ERRORS OCCUR WITH SIGNIFICANT FREQUENCY," AND LISTS NINE CASES INVOLVING TUBING MISCONNECTIONS THAT HAVE BEEN REPORTED TO THE JOINT COMMISSION'S SENTINEL EVENT DATABASE. SUBSEQUENTLY, DATASCOPE MADE THE BUSINESS DECISION TO ASSIST OUR CUSTOMERS IN PREVENTING THESE TYPES OF INCIDENTS FROM OCCURRING FORWARD GOING BY DISCONTINUING NIBP ACCESSORIES WITH LUER CONNECTORS. A LETTER ANNOUNCING THE DISCONTINUATION OF THESE PRODUCTS AND RECOMMENDATIONS FOR PURCHASING QUICK CONNECT CUFFS WAS SENT TO DATASCOPE CUSTOMERS ON JULY 13TH. THE DATASCOPE NATIONAL ACCOUNTS MANAGER DETERMINED THAT HOSP HAD ORIGINALLY PURCHASED QUICK CONNECT FITTINGS WITH THEIR SYSTEM, AND HAD ELECTED TO SWITCH TO LUER FITTINGS THEMSELVES. HE VISITED CORPORATE OFFICES ON 7/28 TO DISCUSS SWITCHING THEIR LUER FITTINGS BACK TO THE QUICK CONNECT TYPE FITTING DATASCOPE HAD ORIGINALLY PROVIDED. HE PROVIDED THEM WITH A SECOND COPY OF THE JCAHO ARTICLE AND DATASCOPE ANNOUNCEMENT LETTER. THEY CONDUCTED AN INFORMATIONAL TRAINING SESSION FOR MEMBERS OF THEIR OWN STAFF DISCUSSING THE POSSIBLE MISCONNECTION OF TUBING AND CATHETER FITTINGS, FOR WHICH DATASCOPE PROVIDED EXAMPLES OF ACCESSORIES WITH BOTH LUER FITTINGS AND QUICK CONNECT FITTINGS. HOSP CONFIRMED THAT THEY SWITCHED THEIR LUER FITTINGS OVER TO THE QUICK DISCONNECT TYPE IN AUGUST.

    Description of Event or Problem · 1

    THE CUSTOMER ADVISED DATASCOPE QUALITY ENGINEERING THAT A CLINICIAN HAD INADVERTENTLY ATTACHED THE NIBP LUER FITTING USED WITH A SPECTRUM MONITOR TO A PATIENT'S IV. THE PATIENT WAS INSUFFLATED, CAUSING AN EMBOLISM, AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRUM PHYSIOLOGICAL MONITOR MHX DATASCOPE CORP. SPECTRUM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death