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

Model Number 3600-100

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Date 09/28/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Report received stated that sterile water was placed in the oasis water chamber.Once the suction tubing was connected to the wall suction, the blue water was noted in the wall suction canister.The team confirmed that the chest drainage system was not accidentally kicked over.There were no defects noted when they were setting up for the procedure or after set-up.

Manufacturer Narrative

Based on the details of the complaint the sterile water that is provided had been placed in the water seal chamber as instructed per the instruction for use (ifu) and suction applied to the drain prior to connecting to the patient.The claim was that the blue fluid in the water seal chamber emptied into the suction canister mounted on the wall that is connected to the vacuum source.Multiple questions regarding this complaint were sent to the institution however, after three good faith efforts to obtain more information, no response was received.There were no images provided and the drain was not returned.Without images or the chest drain in question and evaluation of the product cannot be conducted and therefore the complaint cannot be confirmed.A review of the device lot history records was conducted and there were no non-conformances noted during the manufacture of this lot of oasis chest drains.All quality and performance requirements were met.Without more information or the actual product returned a root cause is difficult to determine.If the drain were placed under vacuum for a long period prior to connecting the drain to the patient, there would have been very rapid bubbling in the water seal chamber.Over time, the water in the chamber could evaporate into the drain suction line and ultimately into the canister but for the fluid to pass directly from the water seal chamber into the canister is not feasible as there is no direct fluid flow path from suction source into the water seal chamber.The ifu in the precaution section states the following: patient tube connections, water seal, suction regulator and bellows should be checked regularly to confirm proper operation.The ifu also states in the set up section: connect patient tube to patient.Connect chest drain to patient prior to initiating suction.Connect suction to chest drain.Attach suction line to suction port on top of chest drain.Based on the details of the complaint, the lack or correspondence from the institution, the absence of the physical drain or images of the drain, it cannot be confirmed that the drain was the cause of the complaint.It is likely that the drain was bubbling rapidly that caused some degree of evaporation that condensed in the vacuum line or canister.This cannot be confirmed without having the actual drain for evaluation.H3 other text : not available for return.

Event Description

N/a.

• Brand Name: OASIS SINGLE DRAIN
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 10723159
• MDR Text Key: 214524929
• Report Number: 3011175548-2020-01277
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862110012
• UDI-Public: 00650862110012
• Combination Product (y/n): N
• PMA/PMN Number: K043140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2023
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Device Lot Number: 461309
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1