Event Notification Report for March 23, 2007
U.S. Nuclear Regulatory Commission
Operations Center
EVENT REPORTS FOR
03/22/2007 - 03/23/2007
!!!!! THIS EVENT HAS BEEN RETRACTED !!!!!
!!!!! THIS EVENT HAS BEEN RETRACTED !!!!!
Hospital
Event Number: 43256
Rep Org: LANCASTER GENERAL HOSPITAL
Licensee: LANCASTER GENERAL HOSPITAL
Region: 1
City: LANCASTER State: PA
County:
License #: 37-1186-01
Agreement: N
Docket:
NRC Notified By: ANTHONY MONTAGENESE
HQ OPS Officer: STEVE SANDIN
Licensee: LANCASTER GENERAL HOSPITAL
Region: 1
City: LANCASTER State: PA
County:
License #: 37-1186-01
Agreement: N
Docket:
NRC Notified By: ANTHONY MONTAGENESE
HQ OPS Officer: STEVE SANDIN
Notification Date: 03/23/2007
Notification Time: 19:30 [ET]
Event Date: 03/23/2007
Event Time: 13:00 [EDT]
Last Update Date: 03/28/2007
Notification Time: 19:30 [ET]
Event Date: 03/23/2007
Event Time: 13:00 [EDT]
Last Update Date: 03/28/2007
Emergency Class: NON EMERGENCY
10 CFR Section:
35.3045(a)(1) - DOSE <> PRESCRIBED DOSAGE
10 CFR Section:
35.3045(a)(1) - DOSE <> PRESCRIBED DOSAGE
Person (Organization):
MEL GRAY (R1)
E. WILLIAM BRACH (FSME)
MEL GRAY (R1)
E. WILLIAM BRACH (FSME)
POTENTIAL OVEREXPOSURE INVOLVING BRACHYTHERAPY SOURCE
At 1300 hours on 3/23/07, a male patient received I-125 seed implants for treatment of prostate cancer. The RSO received a call at approximately 1730 hours from the Radiation Oncologist Physicist who had identified that the wrong units were input into the dose planning computer. This resulted in a potential overexposure. A CAT scan is scheduled for Monday, 3/26/07, to verify source placement and more accurately calculate the overexposure. At this time, the preliminary information provided indicates a prescribed dose of 145 Gray with an estimated dose delivery of 155 Gray. The licensee does not believe that there will be any adverse effects to the patient. Following the more accurate calculation the licensee will review whether this notification meets the reporting criteria.
The licensee has notified the prescribing physician of the error.
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.
* * * UPDATE ON 3/28/07 AT 1417 FROM MONTAGENESE TO SNYDER * * *
This event is retracted by the licensee. Since the time of the original notification the licensee has established, by dosimetry readings, that the exposure was below the reporting criteria.
Notified R1DO (Dimitriadis) and FSME EO (Morell).
At 1300 hours on 3/23/07, a male patient received I-125 seed implants for treatment of prostate cancer. The RSO received a call at approximately 1730 hours from the Radiation Oncologist Physicist who had identified that the wrong units were input into the dose planning computer. This resulted in a potential overexposure. A CAT scan is scheduled for Monday, 3/26/07, to verify source placement and more accurately calculate the overexposure. At this time, the preliminary information provided indicates a prescribed dose of 145 Gray with an estimated dose delivery of 155 Gray. The licensee does not believe that there will be any adverse effects to the patient. Following the more accurate calculation the licensee will review whether this notification meets the reporting criteria.
The licensee has notified the prescribing physician of the error.
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.
* * * UPDATE ON 3/28/07 AT 1417 FROM MONTAGENESE TO SNYDER * * *
This event is retracted by the licensee. Since the time of the original notification the licensee has established, by dosimetry readings, that the exposure was below the reporting criteria.
Notified R1DO (Dimitriadis) and FSME EO (Morell).
General Information or Other
Event Number: 43378
Rep Org: WASHINGTON HOSPITAL CENTER
Licensee: BEST VASCULAR, INC.
Region: 1
City: WASHINGTON State: DC
County:
License #:
Agreement: N
Docket:
NRC Notified By: S. MOHAPATRA
HQ OPS Officer: JEFF ROTTON
Licensee: BEST VASCULAR, INC.
Region: 1
City: WASHINGTON State: DC
County:
License #:
Agreement: N
Docket:
NRC Notified By: S. MOHAPATRA
HQ OPS Officer: JEFF ROTTON
Notification Date: 05/21/2007
Notification Time: 15:08 [ET]
Event Date: 03/23/2007
Event Time: 00:00 [EDT]
Last Update Date: 08/09/2007
Notification Time: 15:08 [ET]
Event Date: 03/23/2007
Event Time: 00:00 [EDT]
Last Update Date: 08/09/2007
Emergency Class: NON EMERGENCY
10 CFR Section:
21.21 - UNSPECIFIED PARAGRAPH
10 CFR Section:
21.21 - UNSPECIFIED PARAGRAPH
Person (Organization):
EUGENE COBEY (R1)
SCOTT MOORE (FSME)
EUGENE COBEY (R1)
SCOTT MOORE (FSME)
PART 21 DEFECT - BRACHYTHERAPY SEEDS UNABLE TO RETURN TO TRANSFER DEVICE AFTER TREATMENT
"Identification of the facility, the activity, or the basic component supplied for such facility or such activity within the United States which fails to comply or contains a defect:
"Facility: Washington Hospital Center;
"Activity: IVRT using a Beta Cath System.
"Identification of the firm constructing the facility or supplying the basic component which fails to comply or contains a defect:
"Best Vascular, Inc. (formerly known as Novoste Corporation).
"Nature of the defect or failure to comply and the safety hazard which is created or could be created by such defect or failure to comply:
"The patient is treated with beta radiation using the Beta Cath device. For the treatment, the sources are monitored and confirmed in the correct treatment position by fluoroscopy. At the completion of treatment, sometimes the seeds are unable to return to the transfer device. Therefore, the beta-rail catheter with all the seeds in it is taken out immediately and placed in the bail out box. The box is then transported back to the storage area. Patient and the area are surveyed to ensure that they are free from all radiation sources. The patient receives the full dose as prescribed. No additional or unnecessary dose is delivered to the patient. There were no medical events. The hospital's Radiation Safety Officer and Best Vascular (Novoste) are notified when this incident occurs. A faulty device is returned to the manufacturer and not used on patients. An incident report is filed for each incident. The device with the catheter is shipped back to Best Vascular for disposal and a new replacement source is requested. The incident is deemed as equipment malfunction. It is an inherent problem with the device itself.
"The date on which the information of such defect or failure to comply was obtained:
"2007: 1/18/07, 2/12/07, 3/7/07 and 3/23/07
"2006: 9/7/06, 11/6/06
"2005: 2/18/05, 4/8/05, 4/14/05, 8/3/05, 10/6/05
"In the case of a basic component which contains a defect or fails to comply, the number and location of all such components in use at, supplied for, or being supplied for one or more facilities or activities subject to the regulations in this part:
"The device consists of a hydraulic system and it fails while retracting the sources after the treatment is complete. It happens for both 60 mm and 40 mm devices that we currently use.
"The corrective action which has been, is being, or will be taken; the name of the individual or organization responsible for the action; and the length of time that has been or will be taken to complete the action:
"Corrective Action: The licensee always followed the manufacturer's emergency procedure.
"Organization: Washington Hospital Center
"Any advice related to the defect or failure to comply about the facility, activity, or basic component that has been, is being, or will be given to purchasers or licensees:
"Recommend the vendor to perform an extensive QC test before shipping the device to the customer. It may reduce the number of occurrences."
* * * UPDATE FROM MOHAPATRA TO HUFFMAN AT 13:29 EDT ON 8/9/07 * * *
The licensee was performing another IVRT (Intravascular Radiation Treatment) today (8/9/07 at 10:35 EDT) when the Brachytherapy device failed to retract. The device was using a 60 mm catheter with 24 Strontium-90 seeds. As noted above, the licensee uses a Beta Cath System that were originally supplied by Novoste Corp and are now serviced under Best Vascular, Inc. The catheter with the seeds were immediately removed and placed in a "bail-out" box. The device with the catheter and seeds will be returned to the manufacturer. There was no exposure issue or medical event as a result of this malfunction.
This report is being made to document continued problem with this device as noted in the previous report. The licensee plans to contact the NRC Regional Inspector (Gabriel) about this event. The R1DO ( Summers) and FSME (Zelac) were notified.
"Identification of the facility, the activity, or the basic component supplied for such facility or such activity within the United States which fails to comply or contains a defect:
"Facility: Washington Hospital Center;
"Activity: IVRT using a Beta Cath System.
"Identification of the firm constructing the facility or supplying the basic component which fails to comply or contains a defect:
"Best Vascular, Inc. (formerly known as Novoste Corporation).
"Nature of the defect or failure to comply and the safety hazard which is created or could be created by such defect or failure to comply:
"The patient is treated with beta radiation using the Beta Cath device. For the treatment, the sources are monitored and confirmed in the correct treatment position by fluoroscopy. At the completion of treatment, sometimes the seeds are unable to return to the transfer device. Therefore, the beta-rail catheter with all the seeds in it is taken out immediately and placed in the bail out box. The box is then transported back to the storage area. Patient and the area are surveyed to ensure that they are free from all radiation sources. The patient receives the full dose as prescribed. No additional or unnecessary dose is delivered to the patient. There were no medical events. The hospital's Radiation Safety Officer and Best Vascular (Novoste) are notified when this incident occurs. A faulty device is returned to the manufacturer and not used on patients. An incident report is filed for each incident. The device with the catheter is shipped back to Best Vascular for disposal and a new replacement source is requested. The incident is deemed as equipment malfunction. It is an inherent problem with the device itself.
"The date on which the information of such defect or failure to comply was obtained:
"2007: 1/18/07, 2/12/07, 3/7/07 and 3/23/07
"2006: 9/7/06, 11/6/06
"2005: 2/18/05, 4/8/05, 4/14/05, 8/3/05, 10/6/05
"In the case of a basic component which contains a defect or fails to comply, the number and location of all such components in use at, supplied for, or being supplied for one or more facilities or activities subject to the regulations in this part:
"The device consists of a hydraulic system and it fails while retracting the sources after the treatment is complete. It happens for both 60 mm and 40 mm devices that we currently use.
"The corrective action which has been, is being, or will be taken; the name of the individual or organization responsible for the action; and the length of time that has been or will be taken to complete the action:
"Corrective Action: The licensee always followed the manufacturer's emergency procedure.
"Organization: Washington Hospital Center
"Any advice related to the defect or failure to comply about the facility, activity, or basic component that has been, is being, or will be given to purchasers or licensees:
"Recommend the vendor to perform an extensive QC test before shipping the device to the customer. It may reduce the number of occurrences."
* * * UPDATE FROM MOHAPATRA TO HUFFMAN AT 13:29 EDT ON 8/9/07 * * *
The licensee was performing another IVRT (Intravascular Radiation Treatment) today (8/9/07 at 10:35 EDT) when the Brachytherapy device failed to retract. The device was using a 60 mm catheter with 24 Strontium-90 seeds. As noted above, the licensee uses a Beta Cath System that were originally supplied by Novoste Corp and are now serviced under Best Vascular, Inc. The catheter with the seeds were immediately removed and placed in a "bail-out" box. The device with the catheter and seeds will be returned to the manufacturer. There was no exposure issue or medical event as a result of this malfunction.
This report is being made to document continued problem with this device as noted in the previous report. The licensee plans to contact the NRC Regional Inspector (Gabriel) about this event. The R1DO ( Summers) and FSME (Zelac) were notified.