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

Model Number 3600-100

Device Problem Material Discolored (1170)

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

Event Date 02/24/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

(b)(6), an icu rn, called for assistance with an oasis chest drain.She reported that this is ¿the third drain to come out of the or with grey water.¿ the nurse mentioned again that this had occurred several times.On one of these drains, i noticed that the drain had clearly tipped over as there was the same-colored drainage in all three columns at different levels.The nurse stated that the drain tipped over in the or and came to her like that.I had her ask the or what type of solution they had used to fill the water seal column (using the ampule, using water from the or table, etc).She reported back that they had used the ampule in all three cases.(b)(6) verified the drains were all working appropriately with no issue.She also wasn¿t sure if all three situations occurred in a row.

Manufacturer Narrative

Correction: d2a - product code.Investigation summary: this parent investigation includes three complaints: (b)(4).All three complaints were received from the same hospital in a single call.An icu nurse called to report that the water in the water seal of three drains appeared grey instead of blue when she received their respective patients from the or.While speaking to the nurse, the getinge representative was able to ascertain that the supplied water ampoules had been used to fill the water seal chambers of each drain.They also confirmed that at least one of the drains had been tipped over, allowing drained fluid to move between chambers.A dhr review could not be completed because a lot number was not provided.The ifu provides adequate instructions for setup and use of the device.Complaint trending found that the actual occurrence level did not exceed the anticipated occurrence level.One excursion was identified for the complaint rate exceeding control limits in february 2024, based on receipt of the three related complaints in the same month.A complaint history review was completed which found no similar complaints.A recurring lot number review could not be completed because a lot number was not provided.The information provided by the customer confirms the complaint.They provided a picture that shows the grey water in the water seal chamber.However, they confirmed that the drain had been tipped over and it could be seen in the pictures that drained fluid had moved between chambers.It is likely that the discoloration was a result of contamination by that fluid.However, the knock over was only confirmed for one complaint and the user reported having 3 drains with grey water in the water seal chamber.Without confirmation that all drains were knocked over, it cannot be known for sure that is the cause.No evidence was found to suggest that this issue was caused by manufacturing, materials, design, or labeling.The root-cause of these complaints is impossible to define.H3 other text : device not returned.

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

Corrected information: section d1, d4 - model number, catalog number and udi number additional information: section h10 related mfg report numbers: 3011175548-2024-00078 & 3011175548-2024-00079.

• 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: 18883010
• MDR Text Key: 337761192
• Report Number: 3011175548-2024-00076
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 04/25/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Age: 78 YR
• Patient Sex: Male