MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION DRAINS OASIS DOUBLE; APPARATUS, AUTOTRANSFUSION

Model Number 3620-100

Device Problem Material Twisted/Bent (2981)

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

Event Date 01/31/2022

Event Type  malfunction  

Event Description

It was reported the chest drain had a kinked tubing.

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.

Manufacturer Narrative

A review of the images provided show that there was a kink in the tubing on the patient line as described in the complaint details.The kink in the tubing although undesirable cosmetically still meets the flow requirements of the drain.Atrium medical corporation had introduced enhancements to the atrium chest drain family that simplify packaging and routine set-up of atrium chest drains.These enhancements factored-in clinician workflow exhibit multiple benefits, such as reducing costs associated with medical waste in the hospital as well as reducing manufacturing carbon footprint.As part of this initiative the wall thickness of the patient tube set was modified from.094+/-.012 inches for the 3/8 inch tubing and.094 +/- 0.16 inches on the 1/4 in tubing to a minimum specification of.088 +/-.006 inches.The dimensional changes were still within the original product requirements.Letters of these changes were sent out to the customers and distributers in february 2019.In an effort to ensure the product was still performing properly, a planned engineering study was conducted using 59 samples from inventory that were sterilized 3x times.This study was created to ensure the threshold for airflow going through the tube set did not drop below the required 7.5slpm after applying a 150gram weight to the tube set.The result was that the lowest value recorded was 24.85slpm.This is much higher than the threshold value.Although the kink in the tubing is undesirable the flow is very much still within the 7.5 slpm as stated in the product requirements.Based on the results of the investigation the kink in the tubing still meets the product requirement for flow as determined in the planned engineering study.A design control quality plan was initiated to reverse the change that called for the wall thickness reduction.The changes to revert back to the original wall thickness were completed in october 2021.The product in this complaint was manufactured in february 2021 before the changes were made.Based on the complaint details and investigation the complaint cannot be confirmed as the product has been shown to meet specification.A design control quality plan was initiated to reverse the change that called for the wall thickness reduction.The changes to revert back to the original wall thickness were completed in october 2021.

Event Description

N/a.

• Brand Name: DRAINS OASIS DOUBLE
• Type of Device: APPARATUS, AUTOTRANSFUSION
• 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: 13429463
• MDR Text Key: 285466180
• Report Number: 3011175548-2022-00044
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862112016
• UDI-Public: 00650862112016
• Combination Product (y/n): N
• PMA/PMN Number: K043140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 3620-100
• Device Catalogue Number: 3620-100
• Device Lot Number: 469916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/06/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.