MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH-AT AXIOM SENSIS HEMO LOW; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number 6634633

Device Problem No Device Output (1435)

Patient Problem Insufficient Information (4580)

Event Date 03/03/2022

Event Type  Death  

Event Description

It was reported to siemens that an adverse event occurred while operating the sensis hemo low system.During a procedure, the customer noticed that the invasive blood pressure measurement did not work.The manufacturer was informed by the medical professional that the patient died independently of the failure of the system.Siemens has requested additional information in order to conduct an investigation of the reported event.

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be hardware error.According to the information received, the patient had a cardiac catheterization examination.Due to the health state of the patient, the patient was transferred to the operating room.After the intervention, the patient again had to be treated in the cardiac catheterization laboratory due to the health status.During this second treatment the patient needed resuscitation and died unfortunately.During the second treatment the staff noticed that the invasive blood pressure of the sensis was not working.The doctor confirmed that there is no causal relation between the patients deaths and the recognized failure of the sensis.The log investigation showed that directly after balancing the pressure, the system ran into a read balance timeout.This is indicating that the sensis system was not able to communicate with the external hardware and therefore no invasive pressure waveform was shown.The user was informed of the problem by the error message "axiom sensis could not retrieve the pressure values from the pressure transducers.Check the cables and the pressure transducers and try again." to resolve the problem the "pc1308"-board was exchanged as part of service activity.After the exchange the system worked again as specified.The replaced part was analyzed and tested in the lab.From the visual inspection it can be summarized that the plastic on the entrance of the connection cable was broken.As this only affects the plastic housing, this did not cause the issue.The board was tested in a test environment connected to a patient simulator.No issues could be identified.The spare parts consumption of the pc1308 was checked.Any accumulation of faults or even a possible general fault that would require corrective action of the installed base could not be determined by the investigation.No further issues have been reported since the replacement.

• Brand Name: AXIOM SENSIS HEMO LOW
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 13768798
• MDR Text Key: 287172730
• Report Number: 3004977335-2022-19294
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K150493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Followup
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6634633
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death