BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANGIOFLUSH III

    MDR report key: 1437211 · Received March 31, 2009

    Report

    Report Number
    1319211-2009-00019
    Event Type
    Death
    Date Received
    March 31, 2009
    Date of Event
    March 25, 2009
    Report Date
    March 30, 2009
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT HISTORY RECORD REVIEW: THE REPORTED LOT NUMBER WAS REVIEWED FOR ANY ABNORMALITIES, WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT. NOTHING WAS FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. REVIEW OF RETURNED SAMPLE: THE COMPLAINT SAMPLE IS NOT AVAILABLE FOR EVAL. THE PHYSICIAN AGREED TO SEND PHOTOS OF THE SAMPLE, BUT THEY HAVE NOT YET BEEN RECEIVED. CONCLUSION: THE COMPLAINT INVESTIGATION IS INCONCLUSIVE. THE PRODUCT WAS NOT RETURNED FOR EVAL. THE CAUSE OF THE COMPLAINT APPEARS TO BE USER ERROR. BASED ON THE INFO SUPPLIED BY THE PHYSICIAN, THE SYSTEM WAS NOT CORRECTLY SET UP FOR THE CASE, INTRODUCING ROOM AIR INTO THE PT. A REVIEW OF THE MFG RECORDS INDICATED THAT ALL OF THE DEVICE SPEC AND QUALITY REQUIREMENTS WERE SATISFIED. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: THE INSTRUCTIONS FOR USE (IC 129) STATES: INDICATIONS: THE ADMINISTRATION OF SALINE AND CONTRAST, THROUGH ANGIOGRAPHIC CATHETERS. CAUTIONS: ALL AIR MUST BE REMOVED FROM THE SYSTEM. TURN THE HANDLE TO OPEN POSITION AND ALLOW THE PT'S BLOOD PRESSURE TO BACK-BLEED AND REMOVE THE AIR FROM THE FLUID PATH. THE QUALITY DEPT. HAS BEEN MADE AWARE OF THE PHYSICIAN'S REQUEST FOR ADD'L LABELING. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. NO FURTHER ACTION AT THIS TIME.

    Description of Event or Problem · 1

    DR LEFT A MESSAGE STATING THAT HE HAD CALLED TO DISCUSS THE ANGIOFLUSH III HAVING SERIOUS DESIGN FLAWS TO REPORT TO YOU (ANGIODYNAMICS), THAT MAY HAVE RESULTED IN A POOR OUTCOME TO A PT. DURING A F/U PHONE CONVERSATION, THE PHYSICIAN STATED THE TUBING WAS HOOKED UP BACKWARDS, AND ROOM AIR WAS DRAWN IN INSTEAD OF THE CO2, RESULTING IN A PT DEATH. THE PHYSICIAN FEELS THERE SHOULD BE TAGS TO MARK ALL 4 PORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOFLUSH III FLUID MANAGEMENT SYSTEM KRA ANGIODYNAMICS, INC. 964865

    Patients

    Seq Age Sex Outcome Treatment
    1 Death