MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. LANTIS 8.3 COMMANDER; ACCELERATOR, LINEAR, MEDICAL

Model Number 08148178

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

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 07/01/2014

Event Type  Injury  

Event Description

Siemens was notified on august 14, 2014 that a female patient undergoing mammary gland treatment received 1749 mu instead of the planned 174 mu for the treatment beam at a 305 degree angle on (b)(6) 2014.Reportedly, the first imrt plan was created, checked and approved by the doctor and the physicist.However, when transferring the information to the lantis system and entering the number of monitor units, a typing error must have occurred.The retrospective error was found when the mpe (medical physicist) was consulted on (b)(6) 2014 due to a change in the table position that had to be approved for the patient's treatment.Further treatment was stopped immediately and the error was discussed with the patient and the doctor.The patient was examined and at that time they had generalized reddened skin and a hyperthermia of the mamma.The patient was examined and at that time they had generalized reddened skin and a hyperthermia of the mamma.The patient received medial in a small volume (7.2ccm), a treatment with 65 gy, the mean dose for mamma is 38 gy.The patient was prescribed with cortisone and weekly skin examinations.This reported issue occurred in (b)(6).

Manufacturer Narrative

Siemens became aware of the reported incident on august 14, 2014.The investigation is ongoing and a supplemental report will be submitted upon completion.(b)(6).

• Brand Name: LANTIS 8.3 COMMANDER
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section G): SIEMENS MEDICAL SOLUTIONS USA, INC.
• Manufacturer Contact: marlynne galloway ; 51 valley stream parkway; ms - d02; malvern, PA 19355 ; 6102195361
• MDR Report Key: 4102572
• MDR Text Key: 4716860
• Report Number: 2910081-2014-06841
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K972275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/14/2014

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: 08148178
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2014
• Initial Date FDA Received: 09/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CCNODE SW VERSION V9.2.18