BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACIST

    MDR report key: 916144 · Received September 14, 2007

    Report

    Report Number
    MW5003787
    Event Type
    Malfunction
    Date Received
    September 14, 2007
    Date of Event
    September 13, 2007
    Report Date
    September 13, 2007
    Manufacturer
    ACIST MEDICAL SYSTEMS
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERGOING CARDIAC CATHETERIZATION PROCEDURE UTILIZING ACIST SYSTEM STEM TO INJECT CONTRAST SOLUTION INTO THE LEFT VENTRICLE. THE CONTRAST MEDIA WAS OMNIPAQUE 350. INJECTION RATE WAS 12 CC/SECOND FOR A TOTAL OF 30 CC; PRESSURE LIMIT SET AT 963 PS (DEFAULT); 0.8 RATE OF RISE. INJECTION WAS THROUGH A 5F ANGLED PIGTAIL CATHETER. NEAR THE END OF THE INJECTION (ESTIMATE 20 - 25 CC VOLUME DELIVERED) THE MALE THREADED PORTION OF THE SYRINGE SEPARATED FROM THE SYRINGE BODY. UPON VISUAL INSPECTION AT OUR LEVEL, WE COULD SEE WHERE THE PLASTIC MALE THREADED CONNECTOR ACTUALLY FRACTURED AND BROKE APART. THIS IS RATHER CONCERNING BECAUSE DURING THE INJECTION, THIS CREATED AN "OPEN" SYSTEM EXPOSING THE PT'S VENTRICLE TO AMBIENT AIR VIA THE CATHETER AND INJECTION TUBING. THERE ARE SENSORS TO PREVENT INJECTION OF AIR; HOWEVER, I WOULD NOT RELAY ON THIS AS AN ABSOLUTE IN PREVENTING AIR INJECTION INTO THE PT'S ARTERIAL SYSTEM AT THE LEVEL OF THE LEFT VENTRICLE ASCENDING AORTA. I CONTACTED THE CO SALES REP WHO ACKNOWLEDGE THAT THERE HAVE BEEN PROBLEMS IN THE PAST WITH THE MANUFACTURING PROCESS RESULTING IN SYRINGES COMING APART. I ASKED IF THERE HAD BEEN A RECALL AND HE INDICATED THAT THERE HAD NOT BEEN. I EXPLAINED THAT I HAD NOT BEEN INFORMED BY THE CO IN ANY OFFICIAL MANNER TO LOOK FOR LOT NUMBERS OF BAD PRODUCT. I WAS TOLD THAT THIS PROBLEM HAS NOT BEEN ISOLATED TO A SPECIFIC LOT NUMBER. I WAS TOLD THAT THIS HAS OCCURRED IN ABOUT 12 STATES, BUT NOT REPORTED AS A PROBLEM. I THEN EXPRESSED MY CONCERN ABOUT CONFIDENCE IN THE MATERIALS WE HAD IN STOCK. DON MITMAN HAD A CO REP CONTACT ME. I REPORTED THE INCIDENT TO THE CO REP WHO ASKED ME FOR LOT NUMBERS OF THE DEFECTIVE PRODUCT AND INVENTORY LEVELS. SHE SAID, THEY WOULD EXPRESS SHIP REPLACEMENT PRODUCT TO REPLACE ALL INVENTORY. WE HAVE HAD NUISANCE PROBLEMS WITH THIS SYSTEM IN THE PAST, BUT NOTHING THIS CLEAR AND EVIDENT OF A MATERIALS FAILURE. DATES OF USE: 2007. DIAGNOSIS OR REASON FOR USE: CARDIAC CATHETERIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACIST MULTI-USE SYRINGE KIT DXT ACIST MEDICAL SYSTEMS 1007K

    Patients

    Seq Age Sex Outcome Treatment
    1 YR ACIST SINGLE-USE MANIFOLD KIT| ACIST INJECTOR SYSTEM| ACIST HAND CONTROL