MAUDE Adverse Event Report: GE HEALTHCARE TECHNOLOGIES AVANCE CS2 PRO; GAS MACHINE, ANESTHESIA

Model Number AVANCE CS2 PRO

Device Problems Leak/Splash (1354); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problems Cardiopulmonary Arrest (1765); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477); Blood Loss (2597); No Code Available (3191)

Event Date 07/16/2015

Event Type  Injury  

Event Description

Patient had a mediastinoscopy, thoracotomy, and lobectomy the day prior to this occurrence; on the night of surgery, the patient was hypotensive with bloody drainage > 1liter out of chest tube in critical care unit.Patient was taken emergently to surgery for re-exploration of bleeding and 2 units packed red cells were ordered.While in surgery, the bleeding source was identified, hemoclips applied with good hemostasis.At this point in the operation, anesthesia reported oxygenation issues (decreased oxygen saturation) which rapidly deteriorated.Anesthesiologist noted a significant leak developed with positive pressure ventilation.Troubleshooting of the circuit and ventilator revealed no apparent cause.Patient required re-intubation, successful on second attempt.Patient had asystole and cpr was performed successfully with return of spontaneous circulation.Patient had a period of 1-2 minutes of a non-perfusing rhythm during the cardiac arrest.Procedure was completed and patient was taken to icu in critical but stable condition intubated.The following day the patient was extubated and stable.Patient had an uneventful postop course and was discharged on post-op day 6 in good condition.Additional notes: anesthesia machine, all patient monitoring equipment, and monitoring cables were placed in sequester at the hospital after this occurrence.The patient circuit was not recovered.Clinical engineer (biotech) was called to surgery for this ventilator failure during this procedure.Anesthesiologist stated the machine had an auto ventilation failure during the procedure.The machine was placed into manual ventilation mode and also failed.The machine displayed a leak alarm indicating a leak in the system.Eventually the leak alarm cleared and the case was completed.Ge healthcare was notified of this event; we requested that ge healthcare do an on-site witnessed download to obtain the log records and the permanent history of the anesthesia machine.The root cause of the equipment failure has not been determined yet.
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manufacturer response for anesthesia machine, avancecs2pro (per site reporter)
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ge healthcare rep came on-site at our request to download the alarm log, error log, event log, and key press log.We will request that ge healthcare come on-site to do witnessed non-destructive testing of the anesthesia machine.We are working with the manufacturer to determine the root cause of this event.

• Brand Name: AVANCE CS2 PRO
• Type of Device: GAS MACHINE, ANESTHESIA
• Manufacturer (Section D): GE HEALTHCARE TECHNOLOGIES; 9900 w. innovation dr.; wauwatosa WI 53226
• MDR Report Key: 4949031
• MDR Text Key: 6257451
• Report Number: 4949031
• Device Sequence Number: 1
• Product Code: BSZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: AVANCE CS2 PRO
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/24/2015
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/29/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 72