MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-07-10 for LHN (CYCLOTRON) manufactured by Indiana University Cyclotron Facility.
[2789368]
(b)(4) uses a cyclotron to generate a proton beam that is transmitted to an adjacent cancer treatment center ((b)(6)) where independent physicians (e. G. Radiation oncologists) use the beam to treat certain cancers. As part of the delivery system, the beam passes through a "snout" which helps direct and focus the beam for the specific pt. The snout was designed to include an interlock system to prevent any proton beam administration when the snout is not in place. On (b)(6), some beam was delivered when the snout was not in place. Upon investigation it was determined that this should have been detected by the health care professionals and that a fail safe interlock system in the snout should have prevented this. The responsible medical physicist and others reviewed the situation and confirmed that there was no pt harm as any beam that was delivered was well within all medical tolerances. No other similar events have occurred and there have been no reports of pt harm.
Patient Sequence No: 1, Text Type: D, B5
[9827999]
This is a unique device (this is the only cyclotron made by (b)(4)) and as such there is no model number, brand name, serial number or lot number. There are three 10 cm snouts available for use with the device at (b)(4). Iucf has not distributed any snouts outside of (b)(4). This action applies to all three 10 cm snouts. The cyclotron has an expected life of at least 20 years. The iucf identification number for these actions with (b)(4) is (b)(4). Apparent cause evaluation: the iucf investigation determined that this event is the result of multiple factors including snout design and device operation. First, (b)(4) written procedures require that the snout be in proper alignment before any beam is administered. Medical personnel are also instructed to ensure proper positioning before beam delivery. In addition, the snout (which was purchased from a third party vendor named (b)(4)) includes design features intended to prevent any beam administration if the snout is not in position as a "fail safe" feature. There have been no prior reports of any inappropriate beam delivery. Iucf's engineering investigation of this event and analysis of the design has determined that the snout interlock design is not fail safe. The electro-mechanical design (the combination of mechanical stops, travel mechanisms, and switch wiring) within the interlock system when operating as an integrated system does not, as had been expected, actually operate as a failsafe system. As a result of these factors, the fail safe interlock system did not operate as intended in this case. Extent of condition: the event occurred with the 10 cm snout is treatment room 2. However, that snout design is common to all three 10 cm snouts. Other snout sizes were reviewed and no other snout sizes are affected by this issue. Previous events: no other pts were exposed to inadvertent beam as a result of the event. (b)(4) has confirmed that there have been no other similar events and iucf has had no other reports of similar events. As such, this is an isolated event resulting from a combination of factors not experienced before. Corrective action (preliminary actions): on (b)(4) 2009, an iucf "alert" was issued to (b)(4) that identified the potential issue with the 10cm snout condition and recommended that (b)(4) take additional precautions to ensure that the snout is aligned in the "treatment" position prior to every treatment. As a temporary measure, the "out-of-beam" snout position bracket was removed from all 10cm snouts, thus preventing any possibility of a recurrence of this event. This has no impact on device performance. Engineering is reviewing the design to determine what design changes might be implemented to ensure that the failsafe interlock system operates while the snout is in the "out-of-beam" state.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007456386-2009-00001 |
| MDR Report Key | 2605065 |
| Report Source | 05 |
| Date Received | 2009-07-10 |
| Date of Report | 2009-07-10 |
| Date of Event | 2009-06-30 |
| Date Mfgr Received | 2009-06-30 |
| Device Manufacturer Date | 2004-01-01 |
| Date Added to Maude | 2012-06-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL PARKER, MANAGER |
| Manufacturer Street | 2401 MILO B. SAMPSON LANE |
| Manufacturer City | BLOOMINGTON IN 47408 |
| Manufacturer Country | US |
| Manufacturer Postal | 47408 |
| Manufacturer Phone | 8128552880 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | 7456386-07/10/09-001-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NA |
| Generic Name | LHN (CYCLOTRON) |
| Product Code | LHN |
| Date Received | 2009-07-10 |
| Returned To Mfg | 2009-06-30 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INDIANA UNIVERSITY CYCLOTRON FACILITY |
| Manufacturer Address | 2401 N. SILO B. SAMPSON LANE BLOOMINGTON IN 47408 US 47408 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-07-10 |