MAUDE Adverse Event Report: UNKNOWN

Device Problem Suction Problem (2170)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 08/12/2015

Event Type  No Answer Provided  

Manufacturer Narrative

The review of the event details and description of the product showed that the drain in particular was not an atrium medical product.Atrium drains don't have 'lung appearing green and green pop up at the top of the drain' features or graphs.After several attempts to contact the hospital's initial reporter it was confirmed that the complaint was not an atrium drain and that the complaint was sent to atrium in error.This medwatch is being submitted to clarify the error and to link this mdr with the user facility mdr.

Event Description

Report received described that a chest drain was hooked up and appeared to be working.In the description of the event the nurse describes that when the drainage was checked the drainage system was working with the lung appearing green and the green pop up at the top of the drain.When the physician checked the patient the patient's lung did not appear to be re-expanded on the x-rays.The physician checked all of the drain connections and the suction set-up was pulling suction.The drain was observed to have the green lung present but the pop up was no longer green.The physician ordered a new chest tube drainage kit to be set-up and applied and the patient immediately had 20cc serosanguinous drainage present and a new x-ray showed the patient's lung had re-expanded.

• Brand Name: UNKNOWN
• Type of Device: UNKNOWN
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH 03054 ; 6038645366
• MDR Report Key: 5202293
• MDR Text Key: 30623940
• Report Number: 1219977-2015-00319
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2015
• Type of Device Usage: N
• Patient Sequence Number: 1