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

Model Number 3600-100

Device Problem Unclear Information (4052)

Patient Problems Pneumothorax (2012); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Report received stated that additional training was needed.As a critical patient harm event occurred.No further information was provided regarding the event.

Manufacturer Narrative

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

Event Description

Report received stated that additional training was needed.As a critical patient harm event occurred.No further information was provided regarding the event.

Manufacturer Narrative

The customer reported that a patient was harmed while using this drain.They clarified that they do not believe the drain was responsible and that the staff misused it.They reported that the staff clamped the patient tube, which prevented drainage and caused a pneumothorax to form in the patient.The customer requested that getinge provide some in-service training to their staff.This training was provided.The customer did not return the device, send pictures, or provide a lot number of the device so neither a device evaluation nor a device history evaluation can be completed.However, because the customer said the device performed as intended and that it was user error that caused the event, it cannot be confirmed that the device was nonconforming to its specifications.The device was not operated according to the provided instructions and the customer informed us that the operators' misuse of the device was the cause of the event.Additional training on the use of the device was provided per the customer's request.All evidence provided by the complainant and reviewed during the investigation indicates that the device performed within specification and the labeling was adequate.The root-cause of this complaint is user error.H3 other text: not available for return.

Event Description

N/a.

• Brand Name: DRAINS OASIS 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: 13262010
• MDR Text Key: 285465090
• Report Number: 3011175548-2022-00026
• Device Sequence Number: 1
• Product Code: CAC
• 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: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention