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

Model Number 6634633

Device Problem Use of Device Problem (1670)

Patient Problem Death (1802)

Event Date 10/21/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Resubmission of initial report due to report code error.

Event Description

It was reported to siemens that an adverse event occurred while operating the sensis hemo low system.The customer reported that the system froze during an emergency procedure and a patient subsequently passed away.Prior to the procedure, the system was started and was reported to be working fine.The patient was transferred to the surgical department following cardiac arrest in the emergency room.Once arriving in the department, the patient was connected to a defibrillator per emergency protocol.Cpr was administered approximately twenty eight minutes later when the patient's blood pressure reading was less than 50mmhg.After ten minutes of cpr the sensis recorded a noninvasive pressure of 54/26.Medications were given four minutes later and cpr was continued.While the patient continued to be monitored via the defibrillator, the physician began to insert an intra-aortic balloon pump (iabp) to provide pressure support for the patient.At this point the sensis system froze and an error message appeared.The study was closed and attempts were made to continue with the same error appearing.A system restart was performed and the system started in ep mode with the error message "no license available".The procedure was continued and it was reported that the patient passed away approximately thirty seven minutes later.The patient's previous medical history is not known at this time.Additional details have been requested for investigation.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.Assessment of the reported incident does not indicate that the siemens system was related to the death of the patient.During the event, log file analysis indicates that the sensis had a synchronization error that caused the system to freeze.The error on site led to a restart of the device and a medium-term delay of the procedure as the electrocardiograph (ecg) signal was missing.The customer correctly viewed these parameters with another device as described in the instructions for use (ifu) for such a case.The customer reported that the sensis system did not cause any injuries and the death of the patient was not related to the medical device.The manufacturer is not considering further actions resulting from this event as no systematic error has been recognized.

• Brand Name: SENSIS HEMO LOW
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forccheim, germany 91301 ; GM 91301
• MDR Report Key: 8482646
• MDR Text Key: 140906305
• Report Number: 3004977335-2018-53987
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K150493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• 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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/26/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/26/2018
• Date Manufacturer Received: 03/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death