BRILLIANCE
Report
- Report Number
- 3015777306-2022-00004
- Event Type
- Death
- Date Received
- August 18, 2022
- Date of Event
- September 19, 2019
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Product Code
- JAK
- PMA / PMN Number
- K012009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
NOTE: WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT. WE WILL FILE A FOLLOW-UP EMDR AT THE COMPLETION OF THE INVESTIGATION. INTERNAL CROSS REFERENCE: COMPLAINT (B)(4).
ADDITIONAL NARRATIVE: THE REPORTING INSTITUTION, SERIAL NUMBER, AND MANUFACTURE DATE WERE PROVIDED AND UPDATED WITHIN THE EMDR FOLLOW UP REPORT.
PHILIPS RECEIVED A MEDWATCH (MW5110808) REPORT ON 18-JULY-2020 THAT ALLEGED IMAGE QUALITY ISSUES ON A BRILLIANCE 10 SYSTEM. THE REPORT STATED, THAT ON (B)(6) 2019, A PATIENT RECEIVED A CT SCAN AND DIED OF COMPLICATIONS FROM BLADDER CANCER IN 2020. THE AREA OF THE BODY THAT WAS SCANNED AND THE CLINICAL IMPLICATIONS FOR WHICH THE SCAN WAS ORDERED WERE NOT NOTED. AN INVESTIGATION WAS PERFORMED, AND IT WAS DETERMINED THAT THE EVENT OF DEATH IS NOT DUE TO THE SYSTEM. IT IS REPORTED THAT THE PATIENT HAD A HIP PROSTHESIS OF WHICH SOME OF THE HARDWARE CONSISTED OF TITANIUM ALLOY. SUBSEQUENTLY, A REVIEW PERFORMED BY THE COMPLAINANT¿S RADIOLOGY EXPERT NOTED THE SCAN TO BE OF POOR QUALITY AND LED TO AN ALLEGED DELAY IN THE DETECTION OF A BLADDER TUMOR FOR APPROXIMATELY 11 MONTHS. IMAGING PATIENTS WITH METALLIC HARDWARE IS KNOWN TO OFTEN RESULT IN SEVERE X-RAY ATTENUATION, CAUSING BEAM HARDENING ARTIFACT. THIS TYPE OF ARTIFACT IS RECOGNIZABLE AND CAN BE SO SEVERE THAT THE ADJACENT ORGANS CAN BE OBSCURED. THERE ARE SOME POST-PROCESSING TECHNIQUES SUCH AS ADJUSTING THE CT WINDOW AND LEVEL THAT MAY REDUCE THE ARTIFACT. HOWEVER, IT IS UNKNOWN IN THIS CASE IF THE REDUCTION OF THE ARTIFACT WAS ATTEMPTED. AN ARTIFACT FROM TITANIUM SHOULD BE RECOGNIZABLE TO THE RADIOLOGIST AND THE USE OF THE IMAGE WOULD THEN BE DETERMINED BY THE RADIOLOGIST AND THE PRESCRIBING PHYSICIAN. IF THE RADIOLOGIST WAS UNSATISFIED WITH THE IMAGE QUALITY, THEY WOULD LIKELY ORDER A RESCAN. THE PATIENT¿S MEDICAL HISTORY, PROGRESSION OF SIGNS AND SYMPTOMS, ANCILLARY TESTS COMPLETED, ADDITIONAL DIAGNOSTIC TESTING, TREATMENT, AND MEDICAL DIAGNOSES ARE UNKNOWN. OUR ENGINEERING TEAM REVIEWED THE AVAILABLE INFORMATION AND THE INVESTIGATION DETERMINED THAT THE DEVICE WAS OPERATING PER SPECIFICATIONS AND ITS INTENDED USE; AND NO FAILURE WAS IDENTIFIED. BASED ON THE ABOVE, IT HAS BEEN CONCLUDED THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME.
NEW ADDITIONAL INFORMATION: INFORMATION WAS RECEIVED FROM THE SUBMITTER OF THE MEDWATCH REPORT WHICH INCLUDED: AGE/DATE OF BIRTH/SEX OF PATIENT. A PHYSICIAN ORDER, DATED (B)(6) 2019 FOR ABDOMEN AND PELVIS CT WITH AND WITHOUT CONTRAST (DIAGNOSIS OF GROSS HEMATURIA). IN ADDITION, IMAGES/REPORT WERE PROVIDED FROM THE HOSPITAL. THERE WAS NO INDICATION IN THE HOSPITAL REPORT OF ARTIFACT OR OF QUESTIONABLE READING DUE TO THE ARTIFACT. AN ADDITIONAL RADIOLOGIST ACQUIRED BY THE SUBMITTER, PERFORMED A REVIEW/INTERPRETATION OF THE DATA WHICH RECOGNIZED THE ARTIFACT AND A BLADDER LESION. THE HOSPITAL RADIOLOGIST AND THE ADDITIONAL RADIOLOGIST HAD CONFLICTING INTERPRETATION OF THE SCANS. SCATTERED ARTIFACT WAS PRESENT AND RECOGNIZED ON THE IMAGES PROVIDED TO PHILIPS FOR REVIEW; DUE TO THE PATIENT'S PROSTHETIC HIP IMPLANT. A CLINICAL HARM REVIEW WAS PERFORMED BASED ON THE ADDITIONAL INFORMATION RECEIVED WHICH RECONFIRMED THAT THE EVENT OF DEATH IS NOT RELATED TO THE SYSTEM. THERE WAS A DIFFERENCE OF OPINION IN THE INTERPRETATION OF THE SCANS BY THE HOSPITAL RADIOLOGIST AND THE RADIOLOGIST ACQUIRED BY THE COMPLAINANT. IMAGING PATIENTS WITH METALLIC HARDWARE IS KNOWN TO OFTEN RESULT IN SEVERE X-RAY ATTENUATION, CAUSING BEAM HARDENING ARTIFACT. THIS TYPE OF ARTIFACT IS RECOGNIZABLE AND CAN BE SEVERE SO THAT THE ADJACENT ORGANS CAN BE OBSCURED. THERE ARE SOME POST-PROCESSING TECHNIQUES SUCH AS ADJUSTING THE CT WINDOW AND LEVEL THAT MAY REDUCE THE ARTIFACT. HOWEVER, IT IS UNKNOWN IN THIS CASE IF REDUCTION OF ARTIFACT WAS ATTEMPTED. AN ARTIFACT FROM TITANIUM SHOULD BE RECOGNIZABLE TO THE RADIOLOGIST AND USE OF THE IMAGE WOULD THEN BE DETERMINED BY THE RADIOLOGIST AND THE PRESCRIBING PHYSICIAN. THEREFORE, THE QUALITY OF THE IMAGE DONE ON (B)(6) 2019 IS UNLIKELY TO HAVE CONTRIBUTED TO THE PATIENTS¿ DEATH APPROXIMATELY 11 MONTHS LATER IN 2020. OUR ENGINEERING TEAM REVIEWED THE AVAILABLE INFORMATION AND THE INVESTIGATION DETERMINED THAT THE DEVICE WAS OPERATING PER SPECIFICATIONS AND ITS INTENDED USE; AND NO FAILURE WAS IDENTIFIED. BASED ON THE ABOVE, IT HAS BEEN CONCLUDED THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME.
SUPPLEMENTAL FOLLOW UP FINAL REPORT #4 IS BEING SUBMITTED. THE COMPLAINT RECORD WAS REVIEWED WHICH IDENTIFIED THAT THE 510K NUMBER ORIGINALLY DOCUMENTED WITHIN THE EMDR REPORTS (K060937) FOR THIS EVENT WAS INCORRECT. THE CORRECT 510K NUMBER IS K012009.
PHILIPS RECEIVED A MEDWATCH REPORT (MW510808) WHICH REPORTED THAT A PATIENT PASSED AWAY IN 2020 DUE TO BLADDER CANCER. THE REPORT ALLEGES THAT THE PATIENT'S BLADDER TUMOR WAS MISSED FROM A SCAN TAKEN ON (B)(6) 2019, DUE TO POOR IMAGE QUALITY. BASED ON THE EVENT DETAILS, THIS IS CONSIDERED A REPORTABLE EVENT. THIS EVENT IS CURRENTLY UNDER INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2370831 | BRILLIANCE | SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED | JAK | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | BR 10 AIR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Female | Death |