BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANTA MULTI-PATIENT DISPOSABLE SET

    MDR report key: 1588343 · Received January 15, 2010

    Report

    Report Number
    2520313-2010-00002
    Event Type
    Malfunction
    Date Received
    January 15, 2010
    Date of Event
    December 16, 2009
    Report Date
    January 15, 2010
    Manufacturer
    MEDRAD, INC.
    Product Code
    FPK
    Removal / Correction Number
    2520313-1/15/10-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISPOSABLE TUBING SET INVOLVED IN THE INCIDENT WAS DISCARDED AND THEREFORE COULD NOT BE EVALUATED BY MEDRAD. ADDITIONALLY, THE SITE WAS UNABLE TO PROVIDE THE LOT # OF DISPOSABLE TUBING SET IN USE DURING THE INCIDENT. OUR RECORDS INDICATE THAT THIS SITE RECEIVED LOT NUMBER 820007 OF THE MULTI-PATIENT DISPOSABLE SET, WHICH IS CURRENTLY UNDER RECALL. THEREFORE, IT IS POSSIBLE THAT THE DEVICE USED DURING THIS EVENT MAY HAVE CONTRIBUTED TO A MALFUNCTION, AS DEFINED IN 21 CFR 803. APPLICATIONS TRAINING WAS OFFERED TO THE SITE AND WAS DECLINED. A MEDRAD SERVICE ENGINEER WENT TO THE SITE ON (B)(6) 2010 TO PERFORM A SYSTEM SERVICE CHECK OF THE INJECTOR. THE RESULTS OF THIS ARE STILL PENDING AND WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE SITE REPORTED THAT A PT WAS BROUGHT INTO THE CARDIAC CATH LAB WITH AN ACUTE MYOCARDIAL INFARCTION. DURING THE CARDIAC CATHETERIZATION, THE STAFF REPORTED THAT THEY VISUALIZED AIR TRAVELING DOWN THE CORONARY ARTERIES. THE CARDIAC CATH LAB MANAGER INDICATED THAT THERE WAS NO MEDICAL INTERVENTION REQUIRED DUE TO THE REPORTED AIR INJECTION AND THAT IT DID NOT AFFECT THE PT'S MEDICAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVANTA MULTI-PATIENT DISPOSABLE SET ANGIOGRAPHIC TUBING SET FPK MEDRAD, INC. 3018231

    Patients

    Seq Age Sex Outcome Treatment
    1