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

Model Number 3600-100

Device Problem Disconnection (1171)

Patient Problem Pneumothorax (2012)

Event Date 04/19/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On the oasis chest drain (3600-100) the place sealed with rubber packing is disconnected.The patient developed pneumothorax.A nurse clamped the product line for sample collection.

Manufacturer Narrative

Investigation: this complaint reports that the "place sealed with rubber packing is disconnected," regarding an oasis drain (p/n: 3600-100).This occurred during a sample collection on a patient who had recently undergone a lung transplant.The patient tube was clamped when the disconnection occurred.A picture (attached) was included showing the drain in a bucket with the patient line disconnected and at the bottom of the bucket.Someone is holding up the strain relief in the center of the picture, disconnected from both the drain and the patient tube.Additional information was requested.The customer stated that the patient had developed a pneumothorax after the disconnection occurred, however they also stated that the patient tube was clamped shut at the time it came disconnected.They stated that the connection did not feel loose when it was checked previously.When they were asked if it was just the strain relief that was disconnected or the patient tube as well, they answered "corrugated tube," indicating the strain relief.This makes it unclear if the patient tube itself was disconnected at the time.The customer was asked if any excessive force was applied to the patient tube and whether they had attempted to sterilize/clean the drain before the event, to both of which they said no.The device was received and decontaminated.It was received with both the patient tube and strain relief taped down over the patient tube nozzle and to the patient line connector.Markings on the drain cover indicate that the drain had collected 380 ml of fluid, much of which was still in the drain.The fluid in the drain was removed and the drain was decontaminated.While the drain was being cleaned, the tape came undone and the patient tube and strain relief fell off the drain.The tube was inspected and no damage or defects were identified.The strain relief was removed from the patient tube to examine the end of the tube and no damage or defects were identified.The outer diameter of the patient nozzle was measured and found to be 0.429 inches, which is within the tolerance given in 002404-001 (body, drain, single, oasis).The patient tube was cut at the midway point to measure the inner diameter, which was found to be 0.374 inches.That is within the tolerance given in 100757 (tubing, non-latex, 63.Tpe/tpr).Pictures of the returned device are attached.Typically the patient tube is very difficult to remove from the patient nozzle without first applying an alcohol solution, which is how the patient tube is initially connected, as described in mp009255 (tube sets, iconic ifu, stopper & stand assembly).According to dd003148 (millennium drains and accessories product requirements) the patient tube connection strength must be able to support the weight of a full drain (=15 lbf for non-pediatric models).A medical assessment was completed which did not identify a link between the patient tube disconnection and the development of a pneumothorax.It notes that the blue clamp was closed during sample collection (when the disconnection occurred) and that the corrugated tube was below the clamp.This means that a disconnection would not have allowed an air leak.Additionally, the patient had just undergone a lung transplant and was at high risk of developing related complications such as pneumothorax.The medical assessment concluded that multiple factors likely lead to the air leak.A review of the dhr and relevant incoming inspection records was completed and no anomalies were identified.No related changes to manufacturing procedures or component designs were identified.The ifu instructs the user not to use the drain if the device or packaging is damaged and to regularly check all connections.No updates to the ifu are needed.Complaint trending found that the actual occurrence level did not exceed the anticipated occurrence level.No excursions were identified.A complaint history review was completed which found no related complaints.A recurring lot number report was completed which found no additional complaints against lot: 487559.A review of cars/capas found no related cars or capas.A review of ncrs found no ncrs related to this complaint.A review of scars found some related to defects which could potentially cause this type of complaint, but none specifically related to it.The incoming inspection records confirmed that these would not have been the cause in this case.The complaint is confirmed, however it cannot be confirmed that the device was nonconforming when it left getinge.The complaint report indicates that when the device was received and set up it was functioning properly.The root-cause of this complaint is impossible to define.

Event Description

N/a.

• 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: 16808930
• MDR Text Key: 313941252
• Report Number: 3011175548-2023-00101
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 00650862110012
• UDI-Public: 00650862110012
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K043140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Device Lot Number: 487559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CHEST TUBE ST 24FR 8.
• Patient Outcome(s): Required Intervention