MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OCEAN; BOTTLE, COLLECTION, VACUUM

Model Number 2002-000

Device Problems Fluid/Blood Leak (1250); Defective Device (2588)

Patient Problem Pneumothorax (2012)

Event Date 10/27/2021

Event Type  malfunction  

Event Description

There was a code blue in the intensive care unit (icu) due to the patient having a pneumothorax.The physician placed a chest tube.When the registered nurse (rn) was setting up the chest tube drainage system, it was defective.When rn put the water in it leaked out.Clinical staff typically stocks two drainage systems but only had one.Presumably because they were on back order.The physician asked for the device several times.The physician had to hook the chest tube up to wall suction for a period while we were waiting.When clinical staff got an additional drainage system, it was not the typical drainage systems that they are trained on.Clinical staff were not sure how to set it up to water seal.Staff retrieved another drainage system and it was the same one that we were not familiar with.The tele critical care doctor said that will work, we just need to put water in it.Health care provider got some sterile water but did not know where to put water into it or how much to use.Health care provider was planning to ask the doctor when materials management brought another drainage system which was the oasis that clinical staff are used to.Rn was able to get it set up quickly.That is what we used on the patient.This caused several delays.Because of the time it took to retrieve an additional chest tube drainage systems, trying to get it set up correctly being unfamiliar with the product.

• Brand Name: OCEAN
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 15410514
• MDR Text Key: 299781059
• Report Number: 15410514
• Device Sequence Number: 1
• Product Code: KDQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2002-000
• Device Lot Number: 240920
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/29/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27010 DA
• Patient Sex: Female