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

Model Number 3650-100

Device Problems Reflux within Device (1522); No Apparent Adverse Event (3189)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Trauma patient with hemothorax had drainage overflow into water seal chamber in a 3650 drain.Nursing educators followed up with nursing staff afterwards to discover that fluid from third chamber and water seal was evacuated and processed before returning to the patient.Conversation with nurses reveal that the original drain was exchanged with a new properly set up device when overflow occurred to allow for autotransfusion.The nurses stated that the entire ats drain was dry (without fluid in any chamber) and the drain was discarded in a biohazard bag.The lot number was not provided and the drain is not available for return and evaluation.

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

The complaint claims that the drain overflowed and some drainage fluid entered the water seal chamber.It is stated that the drain was set up to autotransfuse blood back into the patient and that the drain was later discovered completely empty, including the water seal chamber.The customer believes that all the fluid in the drain, including the water seal fluid, was transfused into the patient.This drain is designed to hold a maximum volume of 2100ml of drained fluid and the ifu instructs users to replace the drain if that maximum volume is exceeded.The customer stated in follow-up communication that the patient drained 2500ml of fluid, causing the overflow.Because the drain was allowed to fill beyond its maximum capacity, it is possible that fluid could leak from the collection chamber into the water seal chamber.The drain is designed so that it will continue draining fluid from the patient even if it exceeds its maximum capacity.This drain contains a collection chamber (split into two columns) and the water seal chamber.As fluid enters the drain, it fills the first column of the collection chamber (which is where the autotransfusion port is located).There is an opening at the top of the column to the second column of the collection chamber.Once fluid reaches the top of the first column, it spills over into the second.Once fluid fills to the top of the second chamber, it has reached its maximum capacity and is intended to be replaced.However, if the drain is allowed to continue overfilling, fluid will pass through another opening at the top of the second collection column into the water seal chamber.Because the only paths between chambers are at the top of the columns, once fluid fills the second collection and or the water seal chamber, it should not be able to travel back through the drain.The only way for that to happen is if the drain is tipped (which is not recommended) or if there is a faulty weld in the divider between the chambers.In the latter case, the faulty welds would need to be right at the bottom of the dividers of the water seal chamber and the two columns of the collection chamber to allow all the fluid to travel backward through the drain.A device with this nonconformance would both be very unlikely to pass inspection and would be very apparent once the drain was put in use, as both collection columns and the water seal chamber would fill simultaneously.The report mentions nothing of the chambers filling simultaneously.The water seal chamber fluid is made of sterile water and fd&c blue no.1, a blue dye commonly used in food coloring.Atrium's toxicologic risk assessment for this dye determined that the minimum amount of the dye required to have an adverse effect on an adult is 36.54 mg/day.The dye ball in the oasis drain's water seal chamber contains approximately 1 mg of the blue dye.When used according to the ifu, the contents of the water seal chamber should never come into contact with the patient, and even if it did, the patient would not be expected to experience any adverse effects as a result.The lot number was not provided and the device was not returned, so a dhr review will not be possible for this investigation.Atrium also has no record of selling this part number to this customer (it is possible they acquired it through a third party supplier), so the lot number cannot be identified through sales history.Based on the details provided by the customer and the information reviewed during the investigation, it cannot be confirmed that the device was non-conforming to its specifications.The leaking of collected fluid into the water seal chamber is consistent with the customers statement that the drain overflowed beyond its maximum capacity.The customers claim that the entire drain was emptied through the autotransfusion port should not be possible when used as indicated.An evaluation of the device and its history could not be completed as the device was not returned and the lot number was not provided.Atrium was unable to identify any evidence that the design or manufacturing of the device would cause this to occur.The passing of fluid from the water seal chamber and the second collection chamber into the first collection chamber is possible if the drain was tipped or knocked over.Additionally, the customer's concern that fluid from the water seal chamber may have been transfused into the patient poses no harm to the patient.Atrium performed a toxicological assessment of the water seal dye and fluid and the amount contained in a single drain is not expected to have any adverse effect on a patient.The root-cause of this complaint is user - operational context.H3 other text: not available for return.

• 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: 11382730
• MDR Text Key: 235011565
• Report Number: 3011175548-2021-00225
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862110036
• UDI-Public: 00650862110036
• Combination Product (y/n): N
• 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: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3650-100
• Device Catalogue Number: 3650-100
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 79 KG