MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SERVO-I; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number SERVO-I

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Event Date 11/01/2019

Event Type  Injury  

Event Description

During literature review, an adverse event was identified in netherlands journal of critical care: neurally adjusted ventilatory assist catheter entering the pleural cavity the patient was admitted to the intensive care unit (icu) requiring noradrenaline, renal replacement therapy and invasive ventilation.After 14 days of mechanical ventilation, a tracheal cannula was inserted.Subsequently, a neutrally adjusted ventilatory assist (nava) catheter was introduced to facilitate ventilation and weaning from the ventilator.The catheter was introduced using forward head flexion and the nurse reported no resistance.According to protocol, the ph of the aspirate was checked to confirm correct placement.The ph of the aspirate was >7 and therefore a chest radiograph was performed to check the position of the inserted catheter.The catheter was inadvertently misplaced in the right bronchus with the tip projecting over the right upper lung field.Computed tomography was performed and confirmed the malposition of the nava catheter in the right lower bronchus, subsequently perforating the right lower lobe of the lung, entering the pleural cavity with the tip toward the apex.No leakage of air was observed on the ventilator, suggesting that the catheter itself plugged the perforation.The surgeon on duty was consulted.Surgical or thoracoscopic removal of the nava catheter was not considered beneficial over manual removal to avoid pneumothorax.Despite careful manual removal of the nava catheter, a tension pneumothorax developed with subsequent asystole cardiac arrest.Cardiopulmonary resuscitation was performed and chest tubes were placed both laterally and ventrally with rapid return of spontaneous circulation.The patient awoke with a good neurological status without any sequelae.After three days the chest tubes were successfully removed.Despite this full recovery, the patient passed away nine days later due to recurrent cholangitis related to the mucinous cystic carcinoma and the decision to withhold escalating interventions.Manufacturer's ref: (b)(4).

Event Description

Manufacturer's ref #: (b)(4).

Manufacturer Narrative

No parts or ventilator logs were returned.Further information was requested but no response has been received.Due to the limited information provided, no investigation has been possible.Therefore the root cause of the reported event has not been determined.

• Brand Name: SERVO-I
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 10948757
• MDR Text Key: 220754156
• Report Number: 3013876692-2020-00068
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SERVO-I
• Device Catalogue Number: 6487800
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/18/2021
• Distributor Facility Aware Date: 02/18/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/18/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2020
• Supplement Dates Manufacturer Received: 02/18/2021
• Supplement Dates FDA Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 65 YR