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

Catalog Number 6487800

Device Problem Contamination (1120)

Patient Problems Death (1802); Inflammation (1932); Cardiac Tamponade (2226); Multiple Organ Failure (3261)

Event Date 06/03/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

It was reported that while the attending nurse was doing a postural change, the ng tube for nava (neurally adjusted ventilatory assist) was accidentally moved, without visual evidence that it was completely removed from the esophagus.With the best of intentions, the attending nurse advanced the ng tube for nava.The nurse indicated that she heard the sound of insufflated air in the abdomen with a stethoscope, but an x-ray was not immediately obtained.Later, the nurse observed enteral feeding content through the endotracheal tube.The enteral feeding was stopped and a direct laryngoscopy by the on-call physician showed that the ng tube for nava was in the lung.The ng tube for nava catheter was completely removed and full ventilator support was indicated.The patient suffered a pneumonitis that progressed to severe ards, multisystem organ failure, and death.Death was caused by cardiac tamponade after cannulation for ecmo.Manufacturer reference#:(b)(4).

Manufacturer Narrative

Our investigation into this complaint has been completed.The information available shows the course of events as billeted below.While the attending nurse was doing a posture change of the patient, the ng tube for nava accidentally got moved but not extubated.The nurse without further consultation pushed back the ng tube for nava to what the nurse thought was the correct original position.The nurse continued with the prescribed enteral nutrition through the ng tube.The nurse observed enteral feeding content through the endotracheal tube and the feeding was stopped.A direct laryngoscopy by the on-call physician showed that the ng tube for nava was in the lung instead of the esophagus.The feeding solution probably caused a pneumonitis that progressed to severe ards, multisystem organ failure,and death.The insertion at the hospital for nava ng tubes is done by physician who also does the necessary checks and tests to verify the correct position.There was no malfunction for the ng tube for nava or inadequate labeling/insertion/positioning information.Although the ng tube for nava had not completely extubated, it had moved out from the esophagus and had required a full insertion procedure including checks and tests that required a physician.The cause of the event was the non-following of the hospital insertion procedures.(b)(4).

Event Description

Manufacturer reference#: (b)(4).

• Brand Name: SERVO-I
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• Manufacturer (Section G): MAGNUS LINDQVIST; maquet critical care ab; röntgenvägen 2, se-171 54; solna ; SW
• Manufacturer Contact: maquet critical care ab; röntgenvägen 2, se-171 54; solna
• MDR Report Key: 7739940
• MDR Text Key: 115711978
• Report Number: 8010042-2018-00393
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K123149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 6487800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 07/04/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 68 YR
• Patient Weight: 100