BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PPD PROVIS PEDISTAL MARK V DYE INJECTOR

    MDR report key: 1040894 · Received May 12, 2008

    Report

    Report Number
    MW5006812
    Event Type
    Injury
    Date Received
    May 12, 2008
    Date of Event
    April 11, 2008
    Report Date
    April 15, 2008
    Manufacturer
    MEDRAD
    Product Code
    DXT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING A LEFT HEART CATHETERIZATION. DURING THE PROCEDURE, AIR REACHED THE LEFT VENTRICLE AND WAS DISPLACED INTO THE RIGHT CORONARY ARTERY. THE PATIENT HAD A MYOCARDIAC INFARCT AND WENT THROUGH A SERIES OF ARRHYTHMIAS TREATED WITH MULTIPLE MEDICATIONS. A BALLOON PUMP AND PACER WIRES WERE PLACED. THE PATIENT WAS STABILIZED AND EVACUATED TO A NEARBY FACILITY WITH HYPERBARIC CAPABILITY. THE PATIENT DID SUFFER A STROKE DURING THE PROCURE AND STILL HAS LEFT SIDED WEAKNESS. IT IS SUSPECTED THAT THE AUTO-INJECTOR USED TO DELIVER CONTRAST MEDIA DURING THE PROCEDURE MALFUNCTIONED WHILE THE PROCEDURE WAS BEING SET UP, ALLOWING A SIGNIFICANT AMOUNT OF AIR TO TRAVEL INTO THE PATIENT'S HEART THROUGH THE CATHETER. THE INJECTOR WAS LEAKING BLOOD AND CONTRAST FLUID AT THE BASE. THE PLUNGER OF THE SYRINGE CONTAINING THE CONTRAST WAS MISALIGNED IN THE SYRINGE. ONE OF THE SPROCKETS ON THE PLUNGER WAS NOT PROPERLY ENGAGED IN THE INJECTOR PISTON CAUSING THE PLUNGER MISALIGNMENT. IT IS UNKNOWN IF THE INJECTOR FAILED TO FUNCTION CORRECTLY, OR THE SYRINGE WAS NOT PROPERLY MANUFACTURED, OR IF HUMAN ERROR SETTING UP THE EQUIPMENT FOR THE PROCEDURE IS THE ROOT CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    THIS IS AN UPDATE OF A REPORT SUBMITTED EARLIER. THE INJECTOR HEAD WAS RETURNED TO SERVICE AFTER BEING EVALUATED AND CHECKED BY THE MFR'S REP. ALL THE STAFF USING THE EQUIPMENT WERE RETRAINED. THE INJECTOR WAS RETURNED TO SERVICE AND DURING ITS FIRST USE, WITH THE COMPANY REP OBSERVING, THE SAME "TURRET" ALARM ACTIVATED ON THE INJECTOR HEAD. THE CORRECT MEASURES WERE TAKEN TO PROPERLY SEAT THE TURRET, HOWEVER, THE ALARM CONTINUED TO SOUND. THE MACHINE WAS REMOVED FROM THE CATH LAB AND THE MFR'S REP TRIED UNSUCCESSFULLY TO PROPERLY SEAT THE TURRET. AT THAT POINT, THE MFR'S REP DETERMINED THAT THE ENTIRE INJECTOR HEAD NEEDED TO BE REPLACED. IT WAS REPLACED AND RETURNED TO THE MFR FOR FURTHER EVAL. THE NEW INJECTOR HEAD WAS INSTALLED AND IS FUNCTIONING CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PPD PROVIS PEDISTAL MARK V DYE INJECTOR DYE INJECTOR DXT MEDRAD

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| L| S