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MAUDE Adverse Event Report

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ADAC LABORATORIES PINNACLE3 RADIATION THERAPY PLANNING SYSTEM RADIATION THERAPY PLANNING SOFTWARE   Back to Search Results
Model Number 9200-00613A-ENG
Event Date 03/26/2004
Event Type  Injury   Patient Outcome  Required Intervention;
Manufacturer Narrative

Evaluation summary: incident investigation determined the reported pt mistreatment issue was limited to one (1) user at one (1) hosp site. The error has been determined to be use error, caused by the user including a radiation block holding tray in treatment plans but omitting the tray during actual radiation treatment. Omission of the tray by the radiation therapist led to overdosing 25 pts by 3% to 13. 5% of the prescribed dose. The hosp has determined that the error occurred because the radiation therapist did not use the prescribed block tray during treatments. Adac pinnacle product labeling was reviewed and determined to be adequate in describing the required use of the block holding tray and its effect on the dose calculation. The adac pinnacle product only develops a treatment plan and is not a therapy treatment device itself. The adac pinnacle product performed as intended and generated treatment plans that included the addition of a block holding tray. The user of the tray is clearly indicated both within the software application, and on the printed report of the plan. There were no product malfunctions involved with the reported events. The tray acts to hold beam blocks, which were not required in these treatment plans. The tray attenuates the beam when used and, to compensate, the dosage is increased in the adac pinnacle calculations.

 
Event Description

A pt mistreatment issue occuring at one (1) hosp site. The reported pt mistreatment issue was an overdose of radiation of between 3% and 13. 5% to twenty-five (25) pts. One (1) pt injury may have resulted in an ulcer.

 
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Brand NamePINNACLE3 RADIATION THERAPY PLANNING SYSTEM
Type of DeviceRADIATION THERAPY PLANNING SOFTWARE
Baseline Brand NamePINNACLE3 RADIATION THERAPY PLANNING SYSTEM
Baseline Generic NameRADIATION THERAPY PLANNING SOFTWARE
Baseline Catalogue NumberNA
Baseline Model Number9200-00613A-ENG
Manufacturer (Section D)
ADAC LABORATORIES
540 alder dr.
milpitas CA 95035
Manufacturer (Section G)
ADAC LAB
540 alder dr
milpitas CA 95035
Manufacturer Contact
randy vader, director
6400 enterprise lane
suite #201
madison , WI 53719
(608) 288 -6945
Device Event Key511444
MDR Report Key522316
Event Key495689
Report Number2916556-2004-00002
Device Sequence Number1
Product CodeIYE
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 04/22/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/23/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number9200-00613A-ENG
Device LOT NumberSOFTWARE VERS. 6.2B
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/26/2004
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/01/2002
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 04/23/2004 Patient Sequence Number: 1
#TreatmentTreatment Date
1,NA
 
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