MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION DRAINS EXPRESS BRU; APPARATUS, AUTOTRANSFUSION

Model Number	4050-100N
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
Chest drain setup prior to chest tube placement.Chamber c (air leak monitor) filled with pre-packaged sterile water to indicated fill line.Drain connected to wall suction.Chamber e (bellow) expanded.Proper setup confirmed by vigorous bubbling in chamber c.After placement of chest tube & connection to drain, it was observed that chamber c had little to no fluid in it.Looked as if there was a spray of fluid inside the chamber.No obvious location of where the fluid went.Although suction was connected to drain & suction tubing was sucking , the drain no longer seemed to have suction.New drain was set up and functioned as designed.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The complaint details state the following: "chest drain setup prior to chest tube placement.Chamber c (air leak monitor) filled with pre-packaged sterile water to indicated fill line.Drain connected to wall suction.Chamber e (bellow) expanded.Proper setup confirmed by vigorous bubbling in chamber c.After placement of chest tube & connection to drain, it was observed that chamber c had little to no fluid in it.Looked as if there was a spray of fluid inside the chamber.No obvious location of where the fluid went.Although suction was connected to drain & suction tubing was sucking, the drain no longer seemed to have suction.New drain was set up and functioned as designed." the device in question was not returned and the product lot number not provided therefore a device history record review could not be conducted.Based on the details the chest drain had the suction applied first prior to connecting the drain to the patient.The first instruction in the instructions for use aw011483 states the following: "set up step 1.Connect patient tube to patient ¿ connect chest drain to patient prior to initiating suction.Step 2.Connect suction to chest drain ¿ attach suction line to suction port on top of chest drain." based on the details provided this instruction was not followed appropriately.When the drain is under suction to atmospheric pressure rapid bubbling will occur and will allow the fluid in the water seal to evaporate rapidly.The details mention that the drain had been bubbling for "several minutes" prior to attaching the drain to the patient chest drain catheter.Being that the drain in question was disconnected and a new drain put in place that functioned properly also suggests that there may have been a poor connection from the chest tube catheter and the drain patient line.Without the drain in question the complaint cannot be confirmed.There was no mention of a leak of the actual drain and no mention of water being on the floor surrounding the drain that suggests a leak of the express chest drain unit itself.As the lot number is unknown of the device a companion/contemporaneous sample was not able to be evaluated.Based on the details provided with the complaint it appears that a set up error of the drain may have contributed to the event and or operational context in regards to the possible air leak between the drain patient line and chest tube catheter.A recurring lot number report was unable to be run as the product lot number was not provided.A review of cars/capas found none related to this complaint.A risk review found that the risk management documents for this product adequately address the reported defect and the severity and anticipated occurrence level are appropriate.H3 other text: device not returned.

• Brand Name: DRAINS EXPRESS BRU
• Common Device Name: APPARATUS, AUTOTRANSFUSION
• 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: 12091572
• Report Number: 3011175548-2021-00718
• Device Sequence Number: 3979816
• Product Code: CAC
• UDI-Device Identifier: 00650862115147
• UDI-Public: 00650862115147
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K043140
• 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): 02/09/2023

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: 4050-100N
• Device Catalogue Number: 4050-100N
• 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: 06/24/2021
• Supplement Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 02/09/2023
• 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 Sex: Unknown