MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION DRAINS OASIS SINGLE; BOTTLE, COLLECTION, VACUUM

Model Number 3600-100

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/25/2023

Event Type  malfunction  

Manufacturer Narrative

Upon completion of the investigation into this event a follow up report will be submitted.

Event Description

Medwatch report notes: elderly male with chest pain.Procedure: coronary artery bypass graft x3.The pleurovac leaked all the fluid from the fluid chamber, no obvious signs of cracks of leaks.No known harm to patient, another one used successfully.

Event Description

N/a.

Manufacturer Narrative

Investigation summary: this complaint reports that all the fluid leaked out of the water seal chamber.It states that there was no additional harm to the patient as a result and that another drain was used successfully.No pictures were provided, but the drain was returned for evaluation.The drain was returned with no obvious damage.The barbed connector was missing and the end of the patient line had been cut off.There was no sign that any drained fluids had entered the drain.The blue dye ball in the water seal column was mostly white and appears to have been exposed to water at some point.There was no fluid in the water seal chamber or anywhere else in the drain.The water seal chamber was filled with water up to the 2cm fill line.Soon after, water began leaking out the bottom of the drain.The leak point was identified as a broken weld in the drain cover, in the bottom left corner just under the water seal chamber.The cover welding was checked around the rest of the drain and the bottom left corner is the only part that was broken.Pulling up on the corner of the cover, melted plastic can be seen from the original weld.There is also a crack in the cover starting near that corner.This strongly indicates that the drain was dropped, which is likely what broke the weld and led to the leak.A dhr review was completed and no anomalies in manufacturing were identified.The ifu provides adequate instructions for use of the device.The user swapped to another device when it became clear that this one was damaged.A review of ncrs found none related to this complaint.This complaint is confirmed and a device nonconformance was also confirmed, however it cannot be determined when the nonconformance occurred.A likely opportunity for the damage to occur during manufacturing was not identified.It most likely occurred during use by the customer.It is suspected that the device fell or was dropped, however an exact cause cannot be identified.The root-cause of this complaint is impossible to define.No evidence was identified to suggest that this complaint is related to design, manufacturing or instructions for use.No escalation is needed.

• Brand Name: DRAINS OASIS SINGLE
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 18110823
• MDR Text Key: 329156053
• Report Number: 3011175548-2023-00196
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 00650862110012
• UDI-Public: 00650862110012
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Device Lot Number: 500313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 85 KG