BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAXTER PRESSURE MONITORING KIT - (ARTERIAL)

    MDR report key: 63797 · Received January 13, 1997

    Report

    Report Number
    63797
    Event Type
    Injury
    Date Received
    January 13, 1997
    Date of Event
    November 22, 1996
    Report Date
    December 3, 1996
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT IN SURGERY FOR LEFT CAROTID ENDARTERECTOMY, HAD HERNIA REPAIR EARLIER IN DAY AND NOTED LATER TO HAVE ACUTE OCCLUSION LEFT INTERNAL CAROTID ARTERY WITH TRANSIENT ISCHEMIC ATTACK. BLOOD PRESSURE READING DURING THE ENDARTERECTOMY CASE RANGED FROM 198 TO 142 SYSTOLIC. DURING RECOVERY ROOM PERIOD, BP ARTERIAL LINE PRESSURE RANGED 172-140 SYSTOLIC AND CUFF PRESSURE WHEN TAKEN VARIED, NOTED 30-40 DEGREES DIFFERENCE. DURING NIGHT SHIFT, NURSING NOTED ARTERIAL LINE PRESSURE WAS FLUCTUATING ABOVE AND BELOW CUFF PRESSURE. DOPAMINE DRIP BEING ADJUSTED DURING THAT TIME PERIOD. NEURO STATUS APPEARS CHANGED SINCE SURGERY.(POST ENDARTERECTOMY STROKE LEFT HEMISPHERE). UNK AT THIS TIME IF STATUS CHANGE IS RELATED TO THE VARYING BP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER PRESSURE MONITORING KIT - (ARTERIAL) Implant PRESSURE TRANSDUCER MONITORING KIT DRS BAXTER HEALTHCARE CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| R