MAUDE Adverse Event Report: SUNMED HOLDINGS LLC SUNMED LLC; BYPASS HME

Model Number DYNJAABHME

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384)

Patient Problem Respiratory Insufficiency (4462)

Event Date 02/21/2024

Event Type  Injury  

Event Description

Patient's secretions went straight through hme and into ventilator circuit. while being suctioned, small amount of secretions went thru the hme and ventilator circuit.Patient not able to move volumes and breathe on the ventilator.

Manufacturer Narrative

The patients secretions going straight into the filter would cause a disruption of therapy.The clinicians inability to suction the secretions would cause a blockage and chocking hazard for the patient.This would cause the patient's oxygen levels to decrease and delay proper ventilation.

Manufacturer Narrative

The patients secretions going straight into the filter would cause a disruption of therapy.The clinicians inability to suction the sexretions would cause a blockage and chocking hazard for the patient.This would cause the patient's oxygen levels to decrease and delay proper ventilation the complaint of "air leaking during intubation, not delivering the patient o2." regarding part number af5140mb/lot 428861 was confirmed.Returned product was investigated.Visual inspection identified a loose diaphragm valve within the bag body and it was concluded that the diaphragm valve was not assembled correctly and became loose prior to end-use.A risk assessment was performed, and the ultimate risk was determined to be high which does require reporting to the capa review board; the complaint was submitted to carb and they decided to open a capa ((b)(4)) for this issue.There have been two (2) other confirmed complaints regarding part number af5140mb for the same issue within the 24 months preceding the reporting of this issue.A memo, containing the complaint investigation, was sent to the customer.Complaints will continue to be monitored for possible trends.

Event Description

Patient's secretions went straight through hme and into ventilator circuit. while being suctioned, small amount of secretions went thru the hme and ventilator circuit.Patient not able to move volumes and breathe on the ventilator.

• Brand Name: SUNMED LLC
• Type of Device: BYPASS HME
• Manufacturer (Section D): SUNMED HOLDINGS LLC; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer (Section G): SUNMED HOLDINGS LLC; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 19148726
• MDR Text Key: 340674527
• Report Number: 1314417-2024-00020
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/19/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: DYNJAABHME
• Device Catalogue Number: DYNHAABHME
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Supplement Dates Manufacturer Received: 03/20/2024
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other