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

Model Number 3600-100

Device Problems Decrease in Suction (1146); Use of Device Problem (1670); Unclear Information (4052)

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

Event Date 04/29/2023

Event Type  malfunction  

Manufacturer Narrative

This mdr is being submitted as part of a retrospective review.During activities being performed for capa 682612 (associated with express mini 500 continued use and use of devices outside of the healthcare setting), atrium medical corp.Became aware of calls received by the getinge emergency support program (esp) team that were not logged as complaints.A retrospective review of the calls logs has resulted in the identification of this complaint/mdr.Upon completion of the investigation into this event a follow up report will be submitted.

Event Description

Rn called to ask about the air leak detection chamber in the oasis.She stated that there is not enough fluid in the chamber, and the float ball is not oscillating.I questioned if there is bubbling from right to left and this is confirmed.The fluid level is at the 2cm mark and i advised that this is the correct amount.She was concerned about a leak somewhere in the system.Walked her through steps to clamp the tube closer to the patient and the bubbles stopped.All connections to the drain and chest tube are secure.I advised that the the presence of the bubbles does confirm that an air leak is present and likely from the patient side after clamping.Advised that she could check to make sure there are no eyelets exposed at the insertion site but it is most likely from the patient as the bubbling is intermittent.

Manufacturer Narrative

Investigation summary: getinge customer service received a call on 4/29/2023 from an oasis (p/n 3600-100) drain user concerned that they may not have enough water in the water seal.They were also concerned that the drain may have an air leak because there was bubbling traveling from right to left in the air leak detection chamber.When asked what level the water was at, the user confirmed it was up to the 2cm fill line.The getinge representative talked the user through checking that all connections were secure and then clamping the patient tube close to the patient.This caused the bubbling cease, indicating the air leak originated from outside the drain system.The user was satisfied with the assistance they received.A dhr review could not be completed because no lot number was provided.The ifu provides adequate instructions for the setup and use of the device.If the instructions to fill and check the water seal chamber had been followed/consulted by the user, it is unlikely this complaint would have occurred.Complaint trending found that the actual occurrence level did not exceed the anticipated occurrence level.No excursions were identified.A complaint history review was completed which found no similar complaints.A recurring lot number report could not be completed because no lot number was provided.A review of crs/capas found none related to this complaint.Neither a lot number or pictures were provided.The device was not returned for evaluation.The assistance provided by the getinge representative determined that the drain was set up correctly and that the air leak was most likely due to patient conditions and not a drain nonconformance.The user's concerns about the drain seemed to be resolved by this call.The most likely cause of this complaint is that the user was uncertain how to set up the drain or how to interpret the air leak detection.This complaint is confirmed but a device nononformance cannot be confirmed.No evidence was identified to suggest that this complaint is related to design, manufacturing or instructions for use.No escalation is needed.The device discussed in this complaint was determined to be functioning normally during the customer service call and no further allegations of device nonconformances were made.The call was made because the user was uncertain if the water seal was filled enough and they were concerned that the bubbling in the air leak detection chamber might indicate a leak within the drain.Getinge's customer service representative was able to determine that the water seal was filled correctly to the 2cm line and aided the user in determining that the air leak originated from the patient and not within the drain system.The root cause of this complaint is user error due to the user being unfamiliar with the setup and interpretation of the drain.

• 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: 18681888
• MDR Text Key: 335944731
• Report Number: 3011175548-2024-00060
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/08/2024

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: 04/29/2023
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: 04/08/2024
• Supplement Dates FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose