MAUDE Adverse Event Report: DATEX-OHMEDA AISYS CS2 ANESTHESIA SYSTEM

Device Problems Occlusion Within Device (1423); Failure to Deliver (2338); Protective Measures Problem (3015)

Patient Problems Hypoxia (1918); Low Oxygen Saturation (2477)

Event Date 10/26/2017

Event Type  Injury  

Event Description

A (b)(6) female developed intraop hypoxic arrest.Following routine checkout of aisys cs2 anesthesia machine and preoxygenation, ga was induced.Pt quickly desaturated and immediately mask ventilated with anesthesia circuit and intubated with glidescope uneventfully.During ventilation using anesthesia circuit, there was no chest rise.Initially, problem with intubation was suspected and ett was immediately changed and another ett was placed uneventfully using direct laryngoscopy.Again, ventilator was not possible using anesthesia circuit.Bag-valve-ett ventilation using stand-alone o2 tank was successful.Pt sustained hypoxic pea arrest and resuscitated with rosc.Inspection of the aisys cs2 anesthesia machine revealed leak test adapter (figure) on the inspiratory flow sensor outlet producing complete circuit obstruction and failure to deliver gas and ventilate the pt.The aisys cs2 user's ref manual recommends preoperative "optional" low p leak test.In the non-acgo aisys cs2 machine, the positive pressure "low p leak" test is listed as "optional" in the electronic checkout menu.Two different types of leak test adapters are available for this purpose.In the non-acgo aisys cs2 system, the mfr recommends occluding the inspiratory flow sensor outlet with the leak test adapter for performing positive pressure "low p leak" test.There are several inherent problems associated with performing positive pressure low p leak" test using mfr provided adapters (especially brown adapter) in he non-acgo aisys cs2.Brown adapter allows operator to attach anesthesia circuit to the outer end of the adapter (figure).This may not be recognized by the operator at the start of the case and result in inability to deliver gas to the pt.There are no "sensors" on the machine end of the leak test adapter, warning the operator or disabling the "start case" function of the machine.The electronic "low p leak" test sequence doesn't provide warning about the hazard of breathing circuit occlusion."start case" function on the electronic display remains active even when the leak test adapter (figure) is attached to the inspiratory flow sensor outlet.This can happen if the leak test adapter is attached to the inspiratory flow sensor outlet and low p leak" test not triggered.In this scenario, all functions of anesthesia machine, except mechanical ventilation, remain operational including volume, pressure and gas monitoring.Apl valve, bag mode, and oxygen flush.The operator of the machine is able to adjust the airway pressure using flows and apl valve while squeezing the bag.However, the leak test adapter does not allow gas delivery from machine to the breathing circuit and the pt due to total occlusion at the inspiratory flow sensor outlet.This creates a dangerous situation and potentially lethal crisis and injury to the pt.In a hypoxic and hypoventilatory crisis situation, anesthesia providers often first focus their attention toward the pt, and not immediately recognize machine related problem (in this scenario, inspiratory flow occlusion by the leak test adapter (figure).Furthermore when compared with other anesthesia machines, the locations of the inspiratory and expiratory flow sensor outlets on aisys cs2 anesthesia machine are not easily visible (hidden under inspiratory and expiratory valve assembly) and any attachments at these outlets are not clearly noticed by the operator.This highlights the fact that this flaw along with hidden position of the flow sensor outlets in aisys cs2 are unsafe features of this machine and all anesthesia providers who use this machine must be aware of these drawbacks.

• Brand Name: AISYS CS2 ANESTHESIA SYSTEM
• Type of Device: AISYS CS2 ANESTHESIA SYSTEM
• Manufacturer (Section D): DATEX-OHMEDA; waukesha WI
• MDR Report Key: 7009638
• MDR Text Key: 91775884
• Report Number: MW5073176
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 13 YR
• Patient Weight: 93