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

Model Number CS2

Device Problem Device Alarm System (1012)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914)

Event Date 04/30/2021

Event Type  malfunction  

Event Description

Patient is toddler-aged female with multiple congenital conditions, including oeis complex (omphalocele-exstrophy-imperforate anus-spinal defects), who presented for planned cloacal exstrophy closure.Intraoperatively, patient became hemodynamically unstable, and interventions performed to stabilize patient.During troubleshooting for cause of hemodynamic changes, it was discovered that the ventilator was alarming for high peep (positive end-expiratory pressure, 8-12 but was set to deliver at 5) and, after troubleshooting the anesthesia ventilator scavenge system, the scavenger bag was noted to be full/taut and the valve in a closed position.After fully opening the scavenger valve, peep decreased, and bp (blood pressure) improved.Approximately one hour later, patient sustained hyperkalemic cardiac arrest and was resuscitated.Period of increased intrathoracic pressure secondary to elevated peep suspected to be one of causal factors leading to metabolic derangements/hyperkalemia for this patient.The hospital recognized opportunities for design modifications to improve the safety of scavenging system on the anesthesia machine, as follows: scavenger valve is easy to manipulate and, if inadvertently bumped, can easily be switched into the closed position without intending to do so (there is no built-in mechanism to prevent accidental valve closure); there is no alert to user if scavenger valve is closed/not scavenging effectively and building too much pressure (when there is a high peep alarm, the user must know to check the scavenger system, but high peep is a non-specific indicator and there are several other factors that could cause it, so a scavenger-specific alarm/alert would help the user narrow down the cause when troubleshooting high peep); the manufacturer recommends the user look at the fullness of the bag to determine whether the scavenging system is working but it is difficult for the user to see the scavenger bag when the anesthesia machine is in use because it is in a hard-to-reach place (i.E., underside/back of machine); there is no way for the user to place the valve in a fixed, open position if desired (i.E., the manufacturer¿s adjustable valve design cannot be modified).

• Brand Name: AVANCE
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): DATEX-OHMEDA INC; 3030 ohmeda drive; madison WI 53718
• MDR Report Key: 13414763
• MDR Text Key: 284823155
• Report Number: 13414763
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CS2
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/28/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 730 DA
• Patient Sex: Female
• Patient Weight: 7 KG