MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION DRAINS EXPRESS SINGLE; APPARATUS, AUTOTRANSFUSION

Model Number 4000-100N

Device Problems Off-Label Use (1494); Use of Device Problem (1670)

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

Event Date 04/30/2021

Event Type  malfunction  

Event Description

Emt called with questions on how to change out an atrium express chest drain.The patient had been sent home from the hospital earlier that day with a chest drain tube attached to an atrium express full size chest drain.The patient and family had not received any teaching of how to change out the chest drain when it became full.However, they were sent home with several additional drains.I reviewed the procedure in detail.By at the time the call ended they had made the decision to take the patient back to the hospital.

Manufacturer Narrative

This mdr is being submitted as part of a retrospective review.During activities being performed for capa 682612 (associated with express mini 500 continued use and use of devices outside of the healthcare setting), atrium medical corp.Became aware of calls received by the getinge emergency support program (esp) team that were not logged as complaints.A retrospective review of the calls logs has resulted in the identification of this complaint/mdr.Upon completion of the investigation into this event a follow up report will be submitted.

Manufacturer Narrative

Investigation summary: an emt called the getinge emergency support team with questions on how to change out an atrium express chest drain.Upon returning the call, the getinge representative spoke in length with the emt discussing the issue.The patient had been sent home from the hospital earlier that day with a chest drain tube attached to an atrium express full-size chest drain.The patient and family had not received any teaching of how to change out the chest drain when it became full.However, they were sent home with several additional drains.The emt stated the home care nurse/admin refused to come see the patient as it was not in their scope.The getinge representative reviewed the procedure with the emt in detail.The emt took the getinge representative¿s direct number to call back if needed, but at the time the call ended they had made the decision to take the patient back to the hospital.They did not name polk mc directly but did imply them as the discharging hospital.The drain in question was an express ii drain catalogue number 4000-100n.This is a full-size model drain and is not intended to be used in a home setting and is not marketed as a mobile device.Based on the details provided the complaint cannot be confirmed, nor has a non-conformance been identified.There is no assertion of an adverse event associated with the use of this express chest drain.The complaint details do mention that the date of event was 04/30/2021.This is at a time period when covid 19 was very much still prevalent, and it is plausible that the physician made a discretionary decision to send a patient home with the full-size drain.A device history record could not be performed as the lot number of the chest drain used was not provided with the complaint.A review of the current instructions for use aw012005 revision aa in the precautions section states: ¿4.Replace chest drain if damaged or when collection volume meets or exceeds maximum capacity.5.Patient tube connections, air leak monitor, vacuum indicator, suction regulator and bellows should be checked regularly to confirm proper operation.8.Users should be familiar with thoracic surgical procedures and techniques before using a chest drain.¿ there is no specific warning or caution within the instructions for use regarding home use of the chest drain.The chest drain was not being used in a clinical setting.There was no known adverse event described in the provided details and no claim of a product performance issue therefore, a contemporaneous sample review is not required.Based on the details of the complaint and investigation results, the complaint has not been confirmed as there was no actual drain non-conformity or adverse event however the investigation has identified that the labeling, specifically the instructions for use do not indicate that the product is only to be used in a clinical setting.In this regard the root cause may be considered design-labeling and the complaint will be escalated to a corrective action request as there is a potential labeling issue.

• Brand Name: DRAINS EXPRESS SINGLE
• 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: 18676626
• MDR Text Key: 335434671
• Report Number: 3011175548-2024-00024
• Device Sequence Number: 1
• Product Code: CAC
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4000-100N
• Device Catalogue Number: 4000-100N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/30/2021
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose