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

Model Number 6FR/50 CM

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Low Oxygen Saturation (2477)

Event Date 05/05/2022

Event Type  Injury  

Event Description

It was reported that the edi catheter became clogged.During troubleshooting procedure to remove the clogging, the patient desaturated to unknown level.The edi catheter¿s clogging will not affect nava function but aspiration and feeding.The final patient outcome was no injury.Manufacturer's ref #: (b)(4).

Manufacturer Narrative

The edi catheter was returned for investigation.Visual analysis found no anomalies, the edi catheter was complete and had no damages.The three feeding holes was found clogged.What type of nutrition that was administered was not stated.A syringe with water or other liquid was connected to the feeding lumen upon return.It was not possible to pump the liquid into the edi catheter.The reported event of a clogged edi catheter was confirmed.As stated in the user manual, the feeding lumen of the edi catheter must be flushed with water after nutrition and medication to prevent clogging.If this was performed is unknown.The inability to provide nutrition via the naso-gastroenteric route of the edi catheter will not affect the nava functionality to transfer electrical activity (edi signals) to the ventilator system.The reported patient desaturation was according to the user facility a consequence of the troubleshooting procedure to remove the clogging from the edi catheter.The root cause of the occluded feeding lumen could not be established but there are no indications that an edi catheter malfunction in any way caused or contributed to the patient desaturation.

Event Description

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: 14495770
• MDR Text Key: 292590465
• Report Number: 8010042-2022-00906
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K153688
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6FR/50 CM
• Device Catalogue Number: 6883899
• Device Lot Number: 3000198343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening