MAUDE Adverse Event Report: NUCLETRON B.V. FLEXITRON; SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/11/2023

Event Type  malfunction  

Event Description

Flexitron hdr treatment software crashed on last 1.5 minutes left of treatment.Emergency backup activated and treatment continued but then went down, manual administration completed.Taken out of service and vendor and biomed notified.Manufacturer response for high dose rate brachytherapy afterloader, flexitron (per site reporter).Vendor will also place a ticket on their end.

• Brand Name: FLEXITRON
• Type of Device: SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED
• Manufacturer (Section D): NUCLETRON B.V.; 400 perimeter center terrace, suite 50; atlanta GA 30346
• MDR Report Key: 18310199
• MDR Text Key: 330278680
• Report Number: 18310199
• Device Sequence Number: 1
• Product Code: JAQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/12/2023
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/12/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25915 DA
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Ethnicity: Hispanic