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

Model Number	2002-000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
It was reported 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 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.
Additional Manufacturer Narrative
The complaint reports that an ocean drain (p/n 2002 000) was being set up for a patient with a pneumothorax and when the nurse added water to the drain it leaked out.The report states that they attempted to set up two more drains but were unfamiliar with how to set them up since they were a different model than they were used to using.No information was provided on the types of drains they were unable to set up and there is no indication they were atrium drains.The patient was hooked directly up to wall suction while the replacement drains were attempted to be set up.The team managed to acquire an oasis drain that they were familiar with and got that set up on the patient.No information was given about the patient's condition after the oasis drain was set up.The complaint description implies that the users were unfamiliar with how to set up the drains that were not the ocean or oasis models.Since there is no indication the drains they were unable to set up were atrium drains, no investigation can be conducted for the reported inability to set up the drains.The lot number they provided for the drain that was reported to have a leak is not associated with any drain device and no pictures were provided.Attempts to obtain the correct lot number from the user facility were unsuccessful and the product was not returned.The provided lot number was not associated with any drain device, therefore a device history record review could not be completed.The ifu cautions the user not to use the drain if it is damaged or becomes damaged during use.It provides adequate instructions for setup and use of the device, including how to add water to the water seal chamber.The iconographic ifu also provides pictorial instructions for the set-up of the drain.Due to a lack of evidence provided by the customer or found during the investigation, neither this complaint nor a device nonconformity can be confirmed.The root-case of this complaint is impossible to define.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 : device not returned.
Event or Problem Description
N/a.

• Brand Name: DRAINS OCEAN SINGLE
• Common Device Name: 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: 15430180
• Report Number: 3011175548-2022-00259
• Device Sequence Number: 12640389
• Product Code: KDQ
• UDI-Device Identifier: 00650862100013
• UDI-Public: 00650862100013
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K043582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2023

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
• Operator of Device: Health Professional
• Device Model Number: 2002-000
• Device Catalogue Number: 2002-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2022
• Supplement Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Female