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

Device Problem Increase in Pressure (1491)

Patient Problem Cardiac Arrest (1762)

Event Date 04/30/2021

Event Type  Injury  

Event Description

Per medwatch report # (b)(4): 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.Ge healthcare will submit a follow-up report when the investigation has been completed.

Manufacturer Narrative

Ge healthcare investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Patient identifier, ethnicity, and race: not provided.Serial number: not provided.Report source other: medwatch report # (b)(4).Date of device manufacture: unknown as no serial number provided.Legal manufacturer: hcs (b)(4).Device evaluation anticipated, but not yet begun.

Manufacturer Narrative

The root cause of the patient experiencing high peep (positive end-expiratory pressure) was determined by the clinician during use: over-pressure resulting from a closed scavenging valve, creating a condition in which pressure could not be relieved from the patient circuit.There is not enough information to determine whether the high peep contributed to the cardiac arrest one hour after the patient experienced high peep.

• Brand Name: AVANCE CS2
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer (Section G): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer Contact: anthony amenson ; 3030 ohmeda drive; madison, WI 53718
• MDR Report Key: 13900738
• MDR Text Key: 287889154
• Report Number: 2112667-2022-00656
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 2 YR
• Patient Sex: Female
• Patient Weight: 7 KG