MAUDE Adverse Event Report: DATEX-OHMEDA, INC AVANCE CS2; ANESTHESIA GAS MACHINE

Device Problems Misconnection (1399); Improper or Incorrect Procedure or Method (2017)

Patient Problem Pneumothorax (2012)

Event Date 12/05/2014

Event Type  Injury  

Event Description

The hospital reported that, prior to intubation, the patient was manually ventilated for approximately 5 minutes.Once the patient was intubated, the patient's co2 level was not where the clinician expected it to be.The endotracheal tube was reportedly removed, and the patient was manually ventilated for a period of time.The patient was then reportedly reintubated, and the co2 did not improve.The patient was again manually ventilated, and the patient was scoped and reintubated.The co2 did not improve.At this point, it was reportedly pointed out to the anesthesiologist that the breathing circuit hose was misconnected.Subsequently, the hose was connected properly.A laparoscope was then placed to begin the surgical procedure.It was then reportedly noted by the surgeon that the patient's diaphragm was not as it should be.A chest x-ray was performed, and a tension pneumothorax was reportedly noted.The case was cancelled.The patient has reportedly recovered and has been discharged from the hospital.

Manufacturer Narrative

Ge healthcare's investigation into the reported occurrence is still ongoing.A follow-up report will be issued when the investigation has been completed.

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the equipment and found it to function within manufacturer's specifications.Logs were downloaded and forwarded to the manufacturing site for analysis.The logs record that, during the reported event, the device was alarming, notifying the user of the reported condition.The device logs do not record any internal malfunctions or errors.The root cause of the reported complaint was due to a use error (improperly connecting the patient breathing circuit from the inspiratory port to the acgo port preventing proper pressure relief).The acgo port is labeled with a graphic that illustrates how to properly connect a patient breathing circuit to the inspiratory and expiratory ports, and how to properly connect a non-circle breathing device to the acgo port.A preoperative checkout of the equipment, as contained in the advance user reference manual, will pick up such a misconnect.

• Brand Name: AVANCE CS2
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC; 3030 ohmeda drive; madison WI 53718
• Manufacturer (Section G): DATEX-OHMEDA, INC; 3030 ohmeda drive; madison WI 53718
• Manufacturer Contact: john szalinski ; 540 w. northwest highway; barrington, IL 60010-3076 ; 8472774719
• MDR Report Key: 4350643
• MDR Text Key: 5222637
• Report Number: 2112667-2014-00125
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 89