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

Model Number	3650-100
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
The report received stated that the red suction bellows of the oasis drain indicated that suction was applied and functioning.But the regulator was set up incorrectly and too low by mistake (-4= 30mmhg).Facility inquired how could the suction still function with the low setting.The instructions for use (ifu) states that the suction source should be set to -80mmhg or higher.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Based on the details provided the drain was functioning properly.The drain in question was not returned and no product lot number was provided.The details provided indicate that the wall suction has been set too low on multiple occasions as the details provided state the wall suction was mistakenly set too low (-4kpa = 30mmhg).The instructions for use aw011482 state that the chest drain suction source should be set to -80 mmhg or higher for chest drain regulator settings of-20 cmh2o or greater.An image of the drain shows that the drain regulator was still set to the factory setting of-20 cmh2o.As the hospital vacuum source was set to -30mmhg the bellows of the chest drain would be fully extended to the delta point as the vacuum source of -30mmhg was greater than the factory set point of -20 cmh2o.As the bellows had reached the delta mark this indicates that sufficient suction had been achieved and the prescribed level of suction has been applied.A device history records review and incoming inspection of the materials could not be conducted as the lot number of the device was not provided.The instructions are clear on how to set up the drain in regards to the amount of suction required.The instruction for use for the oasis chest drain in the precautions section states the following in regards to the proper use and set up of the drain ¿suction source should be set to -80 mmhg or higher for chest drain regulator settings of-20 cmh2o or greater.¿ 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.Based on the details and image provided there is no indication that the chest drain had malfunctioned and the complaint cannot be confirmed.The instruction for use for the oasis chest drain are clear on the proper set up of the drain in regards to the vacuum source settings and therefore the root cause is user error.H3 other text : device not returned.

• Brand Name: DRAINS OASIS 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: 12530601
• Report Number: 3011175548-2021-00996
• Device Sequence Number: 19156382
• Product Code: CAC
• UDI-Device Identifier: 00650862113013
• UDI-Public: 00650862113013
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K043140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2023

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: 3650-100
• Device Catalogue Number: 3650-100
• 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: 08/30/2021
• Supplement Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 03/07/2023
• 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