BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVISION-PLUS

    MDR report key: 5006650 · Received August 11, 2015

    Report

    Report Number
    MW5055396
    Event Type
    Injury
    Date Received
    August 11, 2015
    Date of Event
    August 9, 2015
    Report Date
    August 11, 2015
    Manufacturer
    RYMED TECHNOLOGIES, LLC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    RN ENTERED PT'S ROOM TO FIND PT DIAPHORETIC, TACHYPNEIC, AND CONFUSED. PT WAS IN UNCONTROLLED FIB. PT HAD BEEN RECEIVING ANTIARRHYTHMIC MEDICATION THROUGH CORDIS LINE BUT RN FOUND THAT THE RYMED ENDCAP WAS BROKEN AND ANTIARRHYTHMIC MEDICATION WAS LEAKING INTO THE PT'S BED. THE PT EXPERIENCED A VENTRICULAR RHYTHM AND RESPIRATORY DISTRESS, REQUIRING CPR AND A CODE BLUE TO BE CALLED. THE PT MAY HAVE EXPERIENCED AN AIR EMBOLISM DUE TO THE PT'S CORDIS BEING UNCAPPED AND OPEN TO AIR. THIS EVENT HAPPENED IN THE EARLY MORNING, BY THE AFTERNOON THE PT WAS EXTUBATED AND STABLE. WE HAVE HAD NUMEROUS INCIDENTS REGARDING THE RYMED ENDCAPS BREAKING, DATING BACK TO (B)(6) OF 2014. AT WHICH TIME THE MFR TOOK MULTIPLE ACTIONS TO ADDRESS THE ISSUE. WE WENT MONTHS WITHOUT AN EVENT; HOWEVER IN THE LAST 3 WEEKS WE HAVE HAD A TOTAL OF 3 INCIDENTS WHERE THE RYMED ENDCAP WAS FOUND TO BE BROKEN. THIS EVENT IS THE MOST SIGNIFICANT R/T HARM TO THE PT. WE HAVE NOTIFIED THE MFR AND ARE TRIALING A NEW PRODUCT WITH BAXTER. RYMED TECHNOLOGIES, LLC, MI 49686, USA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527764 INVISION-PLUS ENDCAP FPA RYMED TECHNOLOGIES, LLC RYM-5001CL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening