Event Notification Report for November 3, 2010

U.S. Nuclear Regulatory Commission
Operations Center

Event Reports For
11/02/2010 - 11/03/2010

** EVENT NUMBERS **


46366 46371 46376

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Hospital Event Number: 46366
Rep Org: COMMUNITY HOSPITAL
Licensee: COMMUNITY HOSPITAL
Region: 3
City: MUNSTER State: IN
County:
License #: 13-15882-01
Agreement: N
Docket:
NRC Notified By: MIREL PALAMARU
HQ OPS Officer: STEVE SANDIN
Notification Date: 10/27/2010
Notification Time: 15:45 [ET]
Event Date: 10/26/2010
Event Time: [EDT]
Last Update Date: 10/27/2010
Emergency Class: NON EMERGENCY
10 CFR Section:
35.3045(a)(1) - DOSE <> PRESCRIBED DOSAGE
Person (Organization):
RICHARD SKOKOWSKI (R3DO)
MICHELE BURGESS (FSME)

Event Text

TWO MEDICAL EVENTS INVOLVING RECEIVED DOSE LESS THAN PRESCRIBED DOSE

During an on-site NRC Inspection on 10/26/10, two (2) medical events were identified both involving a delivered dose less than the prescribed dose following implant of Palladium-103 seed for prostate therapy. Specific details as follows:

First Medical Event

Preplanning date: 08/26/09
Post planning date: 09/03/09
D-90 (dose received by 90% of the prostate volume): 72%
Underdose: 28%
Prescribed: Palladium-103, 156U consisting of 65 seeds, 2.4U/seed

Second Medical Event

Preplanning date: 12/08/09
Post planning date: 12/29/09
D-90 (dose received by 90% of the prostate volume): 64%
Underdose: 36%
Prescribed: Palladium-103, 173U consisting of 74 seeds, 2.4U/seed

Both underdoses are attributed to prostate swelling. The physician reviewing the results concluded that there was no adverse impact on either patient. The licensee will continue reviewing medical records to identify any additional occurrences of this nature.

A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.

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General Information or Other Event Number: 46371
Rep Org: IOWA DEPARTMENT OF PUBLIC HEALTH
Licensee: PLASTI-PAINT, INC
Region: 3
City: DE WITT State: IA
County:
License #: 3272123SEM
Agreement: Y
Docket:
NRC Notified By: NANCY FARRINGTON
HQ OPS Officer: JOHN KNOKE
Notification Date: 10/28/2010
Notification Time: 12:06 [ET]
Event Date: 10/28/2010
Event Time: [CDT]
Last Update Date: 10/28/2010
Emergency Class: NON EMERGENCY
10 CFR Section:
AGREEMENT STATE
Person (Organization):
RICHARD SKOKOWSKI (R3DO)
MICHELE BURGESS (FSME)
ILTAB via e-mail ()

This material event contains a "Less than Cat 3" level of radioactive material.

Event Text

AGREEMENT STATE REPORT - IOWA LICENSEE LOST A STATIC ELIMINATOR

The Iowa Department of Public Health provided the following report via e-mail:

"The Iowa Department of Public Health was informed on 10/28/10 that Registrant number 3272-1-0403, Plasti-Paint, lost a Static Eliminator (SN: A2GV069)."

The radionuclide is a 0.01 Ci sealed source of Po-210. The Static Eliminator was manufactured by NRD, Inc, Model number: P-2021-8201. The cause of this loss was human error.


THIS MATERIAL EVENT CONTAINS A "LESS THAN CAT 3" LEVEL OF RADIOACTIVE MATERIAL

Sources that are "Less than IAEA Category 3 sources," are either sources that are very unlikely to cause permanent injury to individuals or contain a very small amount of radioactive material that would not cause any permanent injury. Some of these sources, such as moisture density gauges or thickness gauges that are Category 4, the amount of unshielded radioactive material, if not safely managed or securely protected, could possibly - although it is unlikely - temporarily injure someone who handled it or were otherwise in contact with it, or who were close to it for a period of many weeks. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf

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General Information or Other Event Number: 46376
Rep Org: OHIO BUREAU OF RADIATION PROTECTION
Licensee: CLEVELAND CLINIC FOUNDATION
Region: 3
City: CLEVELAND State: OH
County:
License #: 02110180013
Agreement: Y
Docket:
NRC Notified By: MICHAEL SNEE
HQ OPS Officer: CHARLES TEAL
Notification Date: 10/29/2010
Notification Time: 10:14 [ET]
Event Date: 10/29/2010
Event Time: [EDT]
Last Update Date: 10/29/2010
Emergency Class: NON EMERGENCY
10 CFR Section:
AGREEMENT STATE
Person (Organization):
RICHARD SKOKOWSKI (R3DO)
CHRISTIAN EINBERG (FSME)

Event Text

AGREEMENT STATE - DOSE DELIVERED TO WRONG ORGAN

The following was received from the state of Ohio via email:

"Approximately three (3) weeks prior to therapy, the patient was scanned for extra hepatic shunting through injection of Tc-99m MAA into the hepatic artery per protocol. No shunting to the duodenum was identified.

"On Tuesday, October 26, 2010, at approximately 1455 hours, the patient was treated with 3.959 GBq Y-90 TheraSphere microspheres per protocol. A Interventional Radiologist properly placed catheter, and confirmed by second Interventionist Radiologist.

"On Tuesday, October 26, 2010, at approximately 1930 hours, a post-procedure scan identified significant activity in the duodenum. Initial estimate indicates dose to duodenum approximately 90 Gy (90 Sv).

"Patient has been hospitalized at Cleveland Clinic for observation and possible intervention as a result of dose to the duodenum.

"[The] patient has been notified. [The] referring physician has been notified. [A] literature search indicates patient may have developed vascularization post-scan, pre-treatment."

Ohio Report #: OH 2010-060

A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.

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