BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PSI KIT: 8.5 FR X 4-1/8 (10 CM)

    MDR report key: 1825712 · Received August 27, 2010

    Report

    Report Number
    1036844-2010-00263
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 23, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    KGZ
    PMA / PMN Number
    K781846
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE OPERATING ROOM ANESTHESIA, THE PERCUTANEOUS SHEATH INTRODUCER (PSI) WAS INSERTED INTO PATIENT'S (PT) RIGHT INTERNAL JUGULAR VEIN. PT WAS MOVED TO CARDIOVASCULAR INTENSIVE CARE UNIT (CVICU). THE PA CATHETER (EDWARDS LIFE SCIENCES) WAS USED TO INFUSE THE FOLLOWING: VASOPRESSIN, LEVOPHED AND PROPOPHOL. WHEN THE ATTENDING RN WAS AT THE PT'S BEDSIDE, THE RN NOTICED A DECLINE IN PT'S BLOOD PRESSURE AND AT THIS TIME, THE RN ALSO NOTICED THAT THERE WAS BLOOD IN THE "PA SHEATH." (THE SALES REP CONFIRMED THAT THE CUSTOMER WAS CALLING THE CATH-GARD CONTAMINATION SHIELD A "PA SHEATH"). THE RN NOTICED BLOOD IN THE "PA SHEATH" AS WELL AS, THE PT'S BLOOD PRESSURE (BP) DROPPED AT APPROXIMATELY 24 HOURS AFTER THE PSI WAS INSERTED. IT WAS REPORTED THAT MEDICAL ATTENTION WAS REQUIRED DUE TO LIFE SUSTAINING DRUGS BACKED UP INTO THE CATH-GARD, AND PT DID NOT RECEIVE THE MEDICATION. THE PT'S BP DROPPED TO A SUB-OPTIMAL PRESSURE READING OF 60MMHGP AND PT'S BP HAD TO BE STABILIZED. AS A RESULT, PA CATHETER WAS REMOVED FROM THE PSI AND PSI WAS CAPPED. A SECOND PSI WAS PLACED IN PT'S LEFT INTERNAL JUGULAR VEIN AND CALCIUM WAS GIVEN TO STABILIZE PT'S BP. ONCE THE PT WAS STABLE THE ORIGINAL PSI, WHICH WAS INSERTED INTO PT'S RIGHT INTERNAL JUGULAR VEIN, WAS REMOVED. THERE WAS APPROXIMATELY ONE HOUR DELAY IN THERAPY. THE PT OUTCOME IS LISTED AS "STABILIZED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PSI KIT: 8.5 FR X 4-1/8 (10 CM) CRITICAL CARE PSI PRODUCTS KGZ ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention VASOPRESSIN| PROPOPHOL| LEVOPHED| EDWARDS LIFE SCIENCES 7FR CATHETER