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 Patient Involvement (2645)

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted upon the completion of the investigation into this event.

Event Description

Report received stated that upon opening the drain a permanent kink was noticed on the patient tube.Product was not used.

Manufacturer Narrative

In an effort to enhance the clinician experience and reduce waste, atrium medical corporation 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.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 requirements.Clinical evaluation: the oasis chest drainage system is indicated for the evacuation of air and/or fluid from the chest cavity or mediastinum and to help re-establish lung expansion and restore breathing dynamics.It also facilitates postoperative collection and reinfusion of autologous blood from the patient's pleural cavity or mediastinal area.It is imperative that chest drainage systems and patient status be methodically assessed at frequent and regular intervals.Inspections should include kinking of the tubing, dependent loops, closed clamps, color and character of the drainage, the rate of drainage, the water seal, bubbling (continuous or intermittent) and the negative pressure indicator.H3 other text : device not returned.

• Brand Name: DRAINS OASIS DOUBLE
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 9596524
• MDR Text Key: 175227771
• Report Number: 3011175548-2020-00083
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2022
• Device Model Number: 3620-100
• Device Catalogue Number: 3620-100
• Device Lot Number: 443649
• Date Manufacturer Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention