MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB ENFIT EDI CATHETER; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number ENFIT 12FR/125 CM

Device Problems Material Discolored (1170); Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/06/2021

Event Type  malfunction  

Manufacturer Narrative

Nava is a supported mode of ventilation based on the electrical activity of the diaphragm (edi).Nava delivers assist in proportion to and synchronized with patient breathing efforts.In order for nava to be used, the patient must have an active respiratory drive.Nava requires the insertion of an edi catheter which monitors the edi in all modes and in standby.The edi catheter is a single-use feeding ng (naso-gastric) tube with measuring electrodes positioned in the esophagus so that the measuring electrodes span the movement of the diaphragm.The subjected edi catheter was in place for less than 5 days and was discarded by the healthcare facility.No ventilator logs from the connected ventilator was received.No specific observations or problems were experienced by the healthcare facility during positioning or use.Provided pictures confirms the reported event with a damaged and discoloured tip of the edi catheter.Further information from the healthcare facility stated that the patient was treated with a special drug, oxcarbazepine, orally.The drug was not fluid enough so the edi catheter was blocked.When added pressure, the edi catheter was most likely damaged in the tip.The healthcare facility had experienced the same issue with a normal feeding tube.The feeding lumen of the edi catheter is slightly smaller compared to the feeding lumen of a standard feeding tube of the same size.The reported discolourisation is an effect from the surrounding chemical and biological environment in the stomach and will not affect the performance.The lot no of the subjected edi catheter was not known.No device history record review could therefore be performed.Our conclusion with the available information is that there was no material deficiency.The breakage of the edi catheter was most likely the use of a drug that was not fluid enough and the edi catheter tip then became damaged when pressure was applied.

Event Description

It was reported that during nava (neurally adjusted ventilatory assist) mode of ventilation, the edi signal was poor from the edi catheter.After removing the edi catheter, it was noticed that it was damaged and discoloured in the distal area.There was no patient harm.Manufacturer¿s ref #: (b)(4).

• Brand Name: ENFIT EDI CATHETER
• 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: sara soderholm roman ; roentgenvagen 2; solna
• MDR Report Key: 12646345
• MDR Text Key: 276842363
• Report Number: 8010042-2021-02508
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K153688
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENFIT 12FR/125 CM
• Device Catalogue Number: 6883903
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1