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

Model Number 3600-100

Device Problem Suction Problem (2170)

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

Event Type  malfunction  

Event Description

Report received from consumer that during an inpatient stay for a biopsy, an accidental pneumothorax occurred requiring a chest drain.The consumer reported that the staff was not knowledgeable about the use of the oasis drain (3600-100), and kept the suction line connected to an inactive vacuum source instead of venting to atmosphere in accordance with online educational materials.The consumer has suggested a revision of the 'user manual, videos and in-services' to provide more information.

Manufacturer Narrative

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

Manufacturer Narrative

The details of the complaint indicate that the patient claims that the nursing staff did not know how to properly set up gravity drainage on the oasis drain, which caused a delay in effective treatment.Specifically, he alleged the staff left the drain connected to an inactive suction source when using gravity drainage only.This step is addressed in the ifu.However, he suggested: " review and revise your user manuals, videos, and in-services to always explain the "why" of a critical requirement or step, along with the "what".Based on the details provided by the customer and the information reviewed during the investigation, it cannot be confirmed that the device and labeling were non-conforming to their specifications.The device was not operated according to all the provided instructions and the complainant informed us that the operators' misuse of the device was the cause of the event.The complainant's suggestion that explanation be included in the ifu of why to perform particular actions is not needed, as the intention of the ifu is to provide clear, concise instructions on how to properly use the device.No evidence has been provided to suggest that the device did not function as intended and the complainant refused to provide any additional information that could help confirm the performance of the device.The drain is designed with a positive pressure release valve that will allow fluid to exit the drain so it can continue functioning, even if the suction line remains attached to an inactive suction source.The root-cause for this complaint is undetermined.H3 other text: not available for return.

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: 14411139
• MDR Text Key: 291756217
• Report Number: 3011175548-2022-00141
• Device Sequence Number: 1
• Product Code: KDQ
• 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: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Sex: Male