MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH PRIMUS HI; ACCELERATOR, LINEAR, MEDICAL

Model Number 4504200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Radiation Burn (1755)

Event Type  Injury  

Manufacturer Narrative

Siemens is conducting a thorough investigation into the reported medical issue of the complainant.A supplemental report will be submitted upon completion should further information become available.Device de-installed (b)(6) 2015.

Event Description

A female patient contacted siemens via siemens website, customer inquiry on (b)(6) 2017 to file a complaint regarding an alleged radiation burn received during breast cancer treatment on a primus machine.Siemens made attempts to contact the patient on several occasions via the email address and telephone number provided without success.The patient contacted siemens on november 21, 2017 requesting an explanation from siemens' highest authority as to the de-installation of a primus machine at the facility "immediately after" the patient received treatment.On the same day the patient provided approximate dates of radiation treatment from (b)(6) 2015, name of treatment facility and physician information, along with details of surgical procedures that the patient has undergone since radiation treatment.On december 11, 2017 siemens acquired information from the treatment facility confirming the patient's treatment in connection with a primus hi linac machine that had been de-installed in (b)(6) 2015.The treatment facility's risk management representative confirmed that the primus hi linac machine was de-installed due to a planned equipment upgrade and there were no performance issues reported prior to de-installation.The patient reported on december 18, 2017 that they have recovered from the latest surgery performed on (b)(6) 2017 and is now back to work.

Manufacturer Narrative

The reported device was de-installed in 2015 and is not available for inspection inspect.Service and periodic maintenance records dating from september 2014 through may 2015 for the siemens primus hi system, serial number (b)(4) were reviewed.Based on the analysis of these records, there were no product malfunctions that related to this reported case.The device had received appropriate periodic maintenance per these records.Based on the available information, we are unable to determine the cause of the alleged radiation burn reported by the patient, or whether the device contributed to the burn reported by the patient.Health care practitioners must use their training and expertise when calculating the radiation treatment plans and deciding on the relevant patient care plan (including rt treatment plans and schemes); thus, any side effects of the interaction of radiation with living tissue falls completely in the clinical domain.A review of the associated operator's manual was performed and it was determined to be appropriate and adequate.The supplemental report for mfr report # 3002466018-2017-07055 was submitted to the fda on may 22, 2018 with an incorrect report # (3002466018-2018-07055).The fda contacted siemens healthineers regarding the submission of the initial report and the error was discovered.This report is being re-submitted to the fda with the correct mfr report #.

• Brand Name: PRIMUS HI
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; advanced therapy; roentgen strasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; roentgenstrasse 19-21; roentgen strasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355-9998 ; 6104486484
• MDR Report Key: 7135955
• MDR Text Key: 95420198
• Report Number: 3002466018-2017-07055
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• PMA/PMN Number: K993425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 12/20/2017,12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/20/2017
• Distributor Facility Aware Date: 12/11/2017
• Device Age: 17 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/20/2017
• Date Manufacturer Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/06/1998
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability