MAUDE Adverse Event Report: VIEWRAY, INC. MRIDIAN SYSTEMS; RADIATION THERAPY

Model Number 20000

Device Problems Labelling, Instructions for Use or Training Problem (1318); Radiation Overexposure (3017); Unexpected/Unintended Radiation Output (4028)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2019

Event Type  malfunction  

Event Description

When performing a fraction review of a patient treatment on the mridian linac the user became aware that the patient was treated with 2.5gy (gray) per fraction over 6 fractions for a total of 15gy instead of the intended 2gy per fraction for a total of 12gy.The user prescribed a treatment of 66gy over 33 fractions of 2gy each for the patient.The user initiated treatment using a non-mridian linac system (a varian truebeam system).The patient received 14gy over 7 fractions using the varian system.The user decided to move the treatment regimen for the patient from the truebeam system to the mridian linac system.The user prescribed the remaining dose of 52gy on the mridian linac at 52gy over 26 fractions which resulted in remaining dose and fractions at 2gy each.The user optimized the plan using the original 66gy rather than the remaining 52gy left to be treated to show the full dose.As a result, the per-fraction mu (monitoring unit) was calculated as 66gy over 26 fractions which equals 2.5gy a fraction.The user display clearly indicated that they were optimizing at 66gy and not the intended 52gy.This dose of 66gy was approved by the user in error.This resulted in the patient receiving 3gy more than intended, but did not exceed the cumulative total gy prescribed.The event detailed in this mdr constitutes an accidental radiation occurrence (aro) as defined in 21 cfr 1000.3(a).Per 21 cfr 1002.20(c), this mdr fulfills the aro reporting obligation.

Manufacturer Narrative

Additional manufacturer narrative: date rec¿d by mfr - (b)(6) 2019.This follow-up report adds the recall number associated with this reported event.Other serious (important medical events) was inadvertently checked on the initial report - the complainant confirmed that there was no serious injury for the patient.The reported event occurred with a model 20000; the initial mdr included model 10000 in error.This was a foreign event report; the initial mdr did not have "foreign" checked.

• Brand Name: MRIDIAN SYSTEMS
• Type of Device: RADIATION THERAPY
• Manufacturer (Section D): VIEWRAY, INC.; 815 east middlefield road; mountain view CA 94043
• MDR Report Key: 8430222
• MDR Text Key: 139185887
• Report Number: 3011233554-2019-00001
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• PMA/PMN Number: K170751
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20000
• Device Catalogue Number: 20000
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 3011233554-03-06-2019-1C
• Patient Sequence Number: 1
• Patient Outcome(s): Other