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

Model Number 3600-100

Device Problem Missing Information (4053)

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

Event Date 12/18/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Icu rn who is also the educator, called to question whether the suction tubing could be direct from the wall regulator to the drain, or had to go through a suction canister (collection canister).She expressed dissatisfaction with the diagram for setup that she found online, as well as the fact that no instructions come with the individual drain.It was explained to her that it is irrelevant whether a suction canister is used or not, as long as all the openings on the canister are capped.She was pleased with the help and looks forward to contact from her local rep regarding available posters, etc.She describes their facility as infrequent users, but that this is the drain they always use.

Manufacturer Narrative

A complaint was submitted as a result of a technical support call received regarding oasis 3600-100 and a question on suction application.The complaint details state: "icu rn who is also the educator, called to question whether the suction tubing could be direct from the wall regulator to the drain, or had to go through a suction canister (collection canister).She expressed dissatisfaction with the diagram for setup that she found online, as well as the fact that no instructions come with the individual drain.I explained that it is irrelevant whether a suction canister is used or not, as long as all the openings on the canister are capped.She was pleased with the help and looks forward to contact from her local rep regarding available posters, etc.She describes their facility as infrequent users, but that this is the drain they always use." the territory manager subsequently provided the hospital with oasis wall posters, wallet cards, and personal guide booklets.In addition, in-service training was conducted with the staff.There is no specific device involved in this complaint and no report of device malfunction; therefore, a device evaluation is not required and the complaint is not considered confirmed.As requests for technical support that do not involve possible malfunction/failure are not considered complaints therefore, the focus of this investigation is on the reported dissatisfaction with the labeling configuration (i.E.The fact that no instructions come with the individual drain), and a review of the content of the labeling provided with the drain in regards to suction setup.The ifu was found to contain adequate instruction regarding suction setup.A number of warnings and precautions to ensure proper setup and function of the drain and description of the various features of the drain.There is an image of the drain and features provided, which clearly denotes the suction control regulator, suction monitor, and suction port.The ifu does not require the use of a canister or collection chamber in order to use suction.The iconic ifu provides a graphical depiction of the drain setup, including connection of the suction line, adjustment of the suction regulator, and bellows monitor.A risk review was performed, which concluded that the device is operating within its approved risk profile, and that the risk analysis adequately covers this complaint.Based on the investigation, no labeling deficiencies have been identified with regard to the use of suction.The ifu does not require the use of a suction canister.With regard to the user dissatisfaction with the ifu configuration (i.E.The fact that instructions are not provided with the individual drain), there have been no other related complaints since october 2020.Therefore, root cause is user - user preference issue.H3 other text: no device available.

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: 13110551
• MDR Text Key: 284905741
• Report Number: 3011175548-2021-01352
• Device Sequence Number: 1
• Product Code: KDQ
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2023

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: 3600-100
• Device Catalogue Number: 3600-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 01/05/2023; 02/23/2023
• Supplement Dates FDA Received: 01/06/2023; 03/01/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1