MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SERVO-N; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number SERVO-N

Device Problem Malposition of Device (2616)

Patient Problem Bowel Perforation (2668)

Event Date 03/17/2023

Event Type  Injury  

Event Description

It was reported that prior start of ventilation in nava (neurally adjusted ventilatory assist) mode, there was a gastric perforation when the nasogastric edi catheter was positioned in the stomach.The patient¿s final outcome is unknown.Manufacturer's ref #: (b)(4).

Manufacturer Narrative

The investigation is an evaluation of additional information received per request.No product or ventilator logs were provided for investigation.According to the information from the healthcare facility there was no particular difficulty to introduce and position the edi catheter in place.The patient¿s condition deteriorated directly after the placement of the edi catheter (moderate bradycardia (100 b/min), desaturation <50% for a maximum of 1 min).The gastric bleeding was obstructing the airway.No further attempts was made with nava ventilation.The patient was intubated and ventilation was changed to hfov (high frequency oscillatory ventilation).An x-ray check was performed directly after the incident, which excluded gastric perforation.It is unknown where exactly the bleeding originated from.Final patient outcome was no harm.The impact was an emergency intubation and prolonged intubation.Placement of the edi catheter is performed according to normal hospital routines for feeding tubes.However, in order to find the edi signal (diaphragm activity) the catheter may need to be re-positioned with the help of guidance on the ventilator¿s screen.If the edi catheter is incorrectly positioned, the edi signal would be weak or absent.This is visible on the user interface of the servo ventilator.Warnings and alarms indicates if the edi signal is not synchronized with pressure and flow.There is adequate information in the user¿s manual for calculating of the insertion length and correct positioning of the edi catheter.There is also a calculation tool in the ventilator to suggest the correct edi catheter for the patient and the insertion length.No information has been provided of how and if any of these were utilized by the user.In order not to perforate tissue, the edi catheter is designed with a catheter stiffness as a proven nasogastric tube.The edi catheter also has a rounded tip and is covered with a hydrophilic coating to reduce friction when inserted into the patient.The conclusion is that there was no edi catheter malfunction or inadequate labeling/insertion/positioning information.The root cause of the event has not been determined.H3 other text: 4117.

Event Description

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

• Brand Name: SERVO-N
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer (Section G): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer Contact: caroline kabbabe ; roentgenvagen 2; solna
• MDR Report Key: 16654947
• MDR Text Key: 312413381
• Report Number: 3013876692-2023-00014
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K201874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SERVO-N
• Device Catalogue Number: 6688600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/16/2023
• Distributor Facility Aware Date: 05/11/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/16/2023
• Date Manufacturer Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 7 DA
• Patient Sex: Male