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

Model Number	3600-100
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	07/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that post open heart surgery patient was moved to cicu with all three chest tubes connected to the same suction canister and it was observed that patient's blood pressure started to drop to 60s/30s from 80s/50s.Patient continued to decompensate with worsening vitals and exam.Chest tubes was stripped and irrigated and ecmo was used.As the patient's patch over open chest was bulging, the doctor took the patch down and suctioned out blood and clots from around the heart.The patient's vitals stabilized, their color and pulses improved.The mediastinal chest tube was not suctioning appropriately and chest tubes was troubleshooted by replacing suction tubing for each chest tube and connect each suction tubing to it's own individual suction canister.The suction for the mediastinal chest tube then worked correctly and suctioning blood from around the heart.The patient no longer needed ecmo and then the doctor placed a patch and ioban back over the open chest.
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow-up report will be submitted.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Corrected fields: h3.
Additional Manufacturer Narrative
Additional section: h6.This complaint reports that an oasis drain (p/n 3600-100, l/n 520662) was not adequately draining fluid from a patient.The patient was a 4-month-old infant undergoing open-heart surgery.3 different drains were connected to a single air cannister and were attempting to drain the fluid pooling in the patient's thoracic cavity.The catheters being used were not provided by getinge.They used 15 fr blake chest catheters.The user manually drained some of the fluid and began troubleshooting the drains.The user confirmed that there were no clots or kinks in the tubing.They stated that the bellows were expanded to the delta mark and no air leak was detected in the water seal.The suction tubing of each drain was replaced, and each drain was placed on its own suction source.The drains functioned properly after this, although it is unclear which change corrected the problem.A picture of one of the drains was provided, which shows some collected fluid, the expanded bellows, and the suction regulator set to -20 cmh2o.It should be noted that the adjustable regulators can be set as high as -40 cmh2o, which could have increased the suction and aided in correcting the issue.Two other drains can be partially seen in the picture, presumably the other two drains in the setup.The complete tubing setup cannot be seen so it cannot be fully evaluated from the picture.The device is not being returned for evaluation.It is not known for certain what caused this complaint.It is possible that having all 3 drains connected to the same suction source contributed to the issue.It is also possible that the patch over the thoracic cavity was not fully sealed, opening the system to atmospheric pressure.It also appears that 3 oasis single drains were used on this infant patient.This is not necessarily problematic, but the larger internal chamber of the oasis single requires more suction to be applied than the oasis pediatric drains which are meant for patients of this age.A combination of these factors may have led to the reported issue.The user made two changes to the drains setup while troubleshooting.They changed out the suction tubing and moved each drain onto its own suction source.This fixed the issue.Because two different factors were changes simultaneously, it cannot be determined which of these adjustments made the difference.Once the change to the setup was made, the catheters were placed back in the patient and the thoracic cavity was patched once again.It is possible that repatching it sealed a leak that was previously present, or the catheters were placed with all openings/eyelets fully submerged.Any of these factors could have helped correct the issue.The suction source, suction tubing, patch, and catheters were provided by the user and are not a part of the device in question.Changes to those resolved the issue, so it is unlikely that the device was the cause of this complaint.A medical assessment was completed for this complaint.It determined that based on the description of the issue and the provided pictures, the drain seems to have been functioning properly.It concluded that this complaint was likely caused by a number of factors, but "it is probable that external suction mismanagement may have been associated with the reported incident." a dhr review was completed and no anomalies in manufacturing were identified.There is no indication that a design, manufacturing specification, test method, manufacturing process, equipment or raw material was the cause of the complaint.A recurring lot number query was conducted for l/n 520662 and there have been no other complaints associated with the production lot of finished goods.The ifu provides adequate instructions for the setup and use of the device.There is no indication that this complaint is related to the ifu.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.A historical review of capa and ncrs was completed, which did not identify any issues directly related to this complaint.A complaint history review did identify one similar complaint that reported an oasis single drain was used on a pediatric patient, which had difficulty achieving the necessary suction.The complaint was attributed to the choice of using a non-pediatric drain on a pediatric patient and using incompatible accessories.The complaint is confirmed, however a device nonconformance is not.The details provided by the user indicate that the accessories, setup, or device selection are the most likely causes of this complaint.The most likely root cause is operational context.

• Brand Name: OASIS
• 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: 22609601
• Report Number: 3011175548-2025-000009
• Device Sequence Number: 5494582
• Product Code: KDQ
• UDI-Device Identifier: 00650862110012
• UDI-Public: (01)00650862110012(17)280527(10)520662
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K043140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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,Followup
• Report Date (Section B): 09/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Device Lot Number: 520662
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: 08/28/2025; 09/19/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 09/04/2025; 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 15 FR. BLAKE DRAIN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 4 MO
• Patient Sex: Female
• Patient Weight: 6 KG