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

Model Number 11007641

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/07/2022

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported event.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed if additional information becomes available.Internal id #: (b)(4).

Event Description

It was reported to siemens that a malfunction occurred while operating the sensis vibe hemo system.Siemens service organization reported that the calculations of the cardiac output value were incorrect.On november 21, 2022, siemens received information that the reported issue may had caused false prescription.However, this information has not been confirmed.Siemens has requested additional information in order to conduct an investigation of the reported event.

Manufacturer Narrative

H10: manufacturer narrative: siemens healthcare completed the investigation of the reported event.The investigation was performed based on expert discussions considering the complaint description, customer service reports, system history, event simulation, and system log files.It was initially reported that the calculation of the cardiac output (co) value, which is the volumetric flow rate of the heart's pumping output per unit time, was twice the expected value.No details on health consequences were provided.The log files confirmed the unusual co value.The co is calculated using the thermodilution method, which is based on a measuring the reference temperature of an injection sample and blood temperature.It could be determined that the reference temperature value changed from around 18-19°c (room temp) to around 5°c between (b)(6) and (b)(6).The reference temperature is measured by the external temperature probe, which in this case was provided by 3rd party manufacturer (edwards), connected to the hemo integrated signal interface box (hisib).The system user interface provides constant information about the used parameters for the co function such as reference temperature, correction factor, catheter type used, etc.The system instruction for use provides adequate guidance on the use the co measurement function, including the note that the co measurements rely on correct injectate temperature.During the on-site intervention it was identified that the used 3rd party reference temperature probe supplied by "edwards" was defective.Edwards was informed about the problem for further investigation.The problem claimed by the customer is not related to the siemens system.The siemens system works as specified.H11 corrected data: h3: device had not been evaluated by manufacturer when the initial report was submitted on december 5, 2022.This field should have been checked "no" in the initial report.

• Brand Name: SENSIS VIBE HEMO
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH-AT; siemenstrasse 1 or; rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1 or rittigfeld 1; rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 15915093
• MDR Text Key: 304811092
• Report Number: 3004977335-2022-52615
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 04056869010199
• UDI-Public: 04056869010199
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K150493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11007641
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2023
• 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