MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. PRIMUS HI; ACCELERATOR, LINEAR, MEDICAL

Model Number 4504200

Device Problems Device Stops Intermittently (1599); Device Displays Incorrect Message (2591)

Patient Problems Overdose (1988); Radiation Exposure, Unintended (3164)

Event Date 03/24/2015

Event Type  Injury  

Event Description

Siemens was notified on (b)(6) 2015 of that during an imrt treatment the machine faulted with a bending magnet and steering fault at beam a11 on the 11th segment.The customer resumed and it faulted again; however, they reloaded and completed the treatment.When the customer looked at mosaiq after completing the treatment they saw that the dose was exceeded and that segment 3 through 11 of beam a11 was delivered to the pt twice.

Manufacturer Narrative

Siemens became aware of the reported incident on (b)(6) 2015 and this mdr is being mailed on (b)(6) 2015.The investigation is on-going and a supplemental report will be submitted upon completion.

Manufacturer Narrative

Siemens'investigation showed that in the case of an imrt beam has been interrupted before the system has delivered radiation, the treatment record for the affected segment beam contained ''0'' delivered mus.The value "0" had caused incorrect behavior of the syngo rt therapist related to the identification of the correct segment(s) for the in-session resumption of the affected beam.It is possible that segments would have been treated more than one time because of this incorrect behavior of the syngo rt therapist, which in this case resulted in an overdose to the patient.Siemens has released an update instruction (th001/15/s - rtt 4.3.1mr2 harmonization software update) as july 2015 that resolves this issue of wrong in-session resumption.

• Brand Name: PRIMUS HI
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.
• Manufacturer (Section G): SIEMENS MEDICAL SOLUTIONS USA, INC.
• Manufacturer Contact: marlynne galloway ; 51 valley stream pkwy; ms - d02; malvern, PA 19355 ; 6102195361
• MDR Report Key: 4778857
• MDR Text Key: 5819286
• Report Number: 2910081-2014-09154
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103606
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,company representative
• Reporter Occupation: Not Applicable
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4504200
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/24/2015
• Initial Date FDA Received: 04/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2240869-08/05/15-0023-C
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR