FDA.reportPublic FDA data

MAUDE MDR 9848462

MDR report key
9848462
Report number
2520313-2020-00011
Event key
0
Event type
3
Date of event
2020-03-09
Date received
2020-03-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
401
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
DIANE ECKERT
Address
1 BAYER DRIVE INDIANOLA PA 15051 US
Phone
724-724-7249
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1STELLANT DUAL CT INJECTORCT INJECTION SYSTEMBAYER MEDICAL CARE INC.DXT58746456SCT DY N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-1801. O

Event Narratives#

N

Patient 1

A SYSTEM SERVICE CHECK OF THE STELLANT CT INJECTOR, SERIAL NUMBER (B)(4), WAS COMPLETED ON MARCH 10, 2020 WHICH CONFIRMED THAT THE INJECTOR WAS OPERATING WITHIN BAYER SPECIFICATIONS. THERE WAS NO EVIDENCE OF EQUIPMENT MALFUNCTION. MULTIPLE DOCUMENTED ATTEMPTS HAVE BEEN MADE TO GAIN SPECIFIC INFORMATION RELATED TO THE REPORTED EVENT; HOWEVER, THESE ATTEMPTS HAVE BEEN UNSUCCESSFUL. THE OFFER OF ADDITIONAL CLINICAL APPLICATIONS TRAINING HAS BEEN MADE TO THE CUSTOMER AND WE ARE AWAITING THEIR RESPONSE. THE SITE CONTINUES TO USE THE STELLANT CT INJECTION SYSTEM AFTER THE REPORTED EVENT WITH NO FURTHER ISSUES REPORTED. IN THE EVENT THAT ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

D

Patient 1

ON MARCH 9, 2020, BAYER MEDICAL CARE RECEIVED INFORMATION THAT A PATIENT WHO WAS UNDERGOING A CT SCAN SUFFERED AN ALLEGED AIR INJECTION WHILE CONNECTED TO A STELLANT CT INJECTION SYSTEM. THE PATIENT WAS REPORTED TO HAVE REQUIRED MEDICAL TREATMENT FOR THE AIR INJECTION; HOWEVER, NO DETAILS WERE PROVIDED.