MAUDE Adverse Event Report: BAYER MEDICAL CARE INC. MEDRAD ANGIOGRAPHIC/CT INJECTOR

Model Number	86410095
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914)
Date of Event	11/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A system service check of the medrad® mark 7 arterion injection system (serial number (b)(6) was completed on november 15, 2023 which confirmed that the injector was operating within bayer specifications.Multiple documented attempts have been made to gain specific information related to the reported event, including the disposables involved; however, these attempts have been unsuccessful.In the event that additional information is obtained, a follow-up report will be submitted.This information does not constitute an admission that the device, the company, or its employees caused or contributed to a reportable event.
Event or Problem Description
On november 15, 2023, bayer medical care inc.Received information that a patient suffered a cardiac arrest while connected to a medrad® mark 7 arterion injection system (serial number (b)(6).The customer reported that the injector failed to respond after being armed.As the staff were attempting to troubleshoot the injector issue, the patient's blood pressure dropped which progressed to cardiac arrest.The customer reported that, after successful resuscitation, the injector was returned to normal operation and the procedure was successfully completed.The customer also reported that the patient has recovered.
Additional Manufacturer Narrative
Udi related data quality updates only.Correction: for udi data discrepancy/mismatch on previously submitted mdr and to ensure the device identification data is in alignment with gudid.

• Brand Name: MEDRAD ANGIOGRAPHIC/CT INJECTOR
• Common Device Name: ANGIOGRAPHIC/CT INJECTOR
• Manufacturer (Section D): BAYER MEDICAL CARE INC.; one bayer drive; indianola PA 15051
• Manufacturer (Section G): BAYER MEDICAL CARE INC.; one bayer drive; indianola PA 15051
• Manufacturer Contact: diane eckert ; one bayer drive; indianola, PA 15051 ; 7249408677
• MDR Report Key: 18303171
• Report Number: 2520313-2023-00034
• Device Sequence Number: 6783573
• Product Code: DXT
• UDI-Device Identifier: 00616258021362
• UDI-Public: (01)00616258021362(11)201105
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K113133
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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
• Operator of Device: Health Professional
• Device Model Number: 86410095
• Device Catalogue Number: ART 700 PEDL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown