MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; HME, BYPASS

Catalog Number DYNJAABHME

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Low Oxygen Saturation (2477)

Event Date 02/21/2024

Event Type  Injury  

Manufacturer Narrative

It was reported by the customer contact that patient's secretions went straight through hme and into ventilator circuit and "plugged off the patient's airway".It was reported that the patient desatted to the 80s.It was reported that due to this, "changed hme and suction ballard and pt was able to pull volumes again".After the replacement, it was reported that "sats came back up to upper 90s".It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

Secretions went straight through hme and into ventilator circuit and "plugged off the patient's airway.".

• Type of Device: HME, BYPASS
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18921937
• MDR Text Key: 337877681
• Report Number: 1417592-2024-00425
• 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
• Type of Report: Initial
• Report Date: 03/18/2024

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?: No
• Device Catalogue Number: DYNJAABHME
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other