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

Model Number 3600-100

Device Problem Unintended Movement (3026)

Patient Problem Pain (1994)

Event Type  malfunction  

Event Description

Customer complaint about the impact of getinge's discontinuation of dual oasis drain.Icu patients are experiencing increased pain, due to my connector being used between x2 thoracic catheters and drain tubing of single oasis drain - therefore pulling the drains inside of patient and also at insertion sites.Internal conversation to continue within the hospital to look at options.This problem did not occur when the drains had separate drainage compartments in dual oasis drain.

Manufacturer Narrative

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

Manufacturer Narrative

Investigation: it was reported that patients using 2 thoracic catheters connected by a y-connector to 3600-100 drains are experiencing pulling and pain at insertion sites when compared to their experience using the discontinued oasis dual drains.The type of catheters used is not known.The customer confirmed that the setup in question has 2 catheters joined at a y-connector, draining into the same drain.The patients' discomfort was due to the physical placement of the catheters and was not related to suction.They stated that five patients have had this experience.No lot numbers or pictures were provided.The customer said the drains will not be returned.This customer's experience occurred due to the discontinuation of the oasis dual drain which caused them to attempt to recreate the same setup by connecting two catheters to a single drain with a y-connector.This setup does not allow the drainage of each insertion site to be measured individually.For more accurate measurement, each catheter should be connected to its own drain.The nature of the complaint is a dissatisfaction with the current catalog of drains rather than a dissatisfaction with the drains' performance.Therefore, the complaint is confirmed.However, there was no indication that the drains did not function properly.Any pulling of the catheters experienced by the patients would be caused by how the drains were physically set up and positioned and is unrelated to their functionality.The complaint of patient discomfort does not allege any deficiencies with the drains and no evidence has been provided to suggest the drains did not perform as intended.It cannot be confirmed that the devices were nonconforming.A dhr review could not be completed because no lot numbers were provided.No changes to the specifications of the drain or its components related to this complaint were identified.The ifu provides adequate instructions for the intended setup of the oasis single collection drain (attached to a single catheter).The customer's complaint indicated they were aware of the identity of the drain, so there is not a concern about mislabeling.However, the ifu does not warn the user not to attach this model drain to multiple catheters.Capa request 769987 has been initiated to evaluate possible updates to the ifu and risk management file to address these findings.A complaint history review was completed which found no related complaints.Because this complaint is about customer dissatisfaction, the complaint is confirmed.No evidence was identified in the investigation to confirm product nonconformity.The hazardous situation/harm is addressed in the harm hazards analysis document which assigns it a severity level of 2.This was determined to be appropriate based on the harm that was reported in the complaint.Complaint trending concluded that the actual occurrence level did not exceed the anticipated occurrence level.H3 other text : not returned.

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: 16227224
• MDR Text Key: 308635777
• Report Number: 3011175548-2023-00014
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 00650862110012
• UDI-Public: 00650862110012
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 02/20/2023

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: 01/18/2023
• Initial Date FDA Received: 01/23/2023
• Supplement Dates Manufacturer Received: 02/17/2023
• Supplement Dates FDA Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1