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

Model Number	3612-100
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Aspiration Pneumonitis (4455)
Type of Reportable Event	Serious Injury
Event or Problem Description
Hospital states: we had a baby tonight with a very large pneumothorax that required needle aspiration and a chest tube.We have the new atrium dry suction collection system and we could not get it to work correctly with our patient.I tried 4 different suction apparatus and changed tubing and every other thing i could change to get it to work including you tube.It would never bubble and show us the air leak and the baby was not improving.Repeat chest xrays just showed same size pneumo.They resolved the issue by using a wet seal/wet suction unit from inventory and as soon as it was hooked up, within 1 minute the water seal was bubbling and you could see the air leak improving and xray looked better.Customer has requested education/training for the nicu unit.
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted.
Additional Manufacturer Narrative
Additional information: section d10.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Additional information: section h6.Corrected information: section d2b.Investigation: this complaint reported that the customer had difficulty using an oasis pediatric drain (p/n 3612-100).When more details were requested, they stated that despite the patient having a pneumothorax, the drain was not bubbling to indicate an air leak.The customer confirmed that the water seal was filled to the 2cm line, the suction regulator was set to -10 and the wall suction was set to -80.They stated that the slide clamp was open and the patient tube was connected to a 8.5 fr pigtail catheter.They said that bubbling in the water seal was only observed when the patient was moved.They changed to another system using the same chest tube and the patient improved.The customer stated that they have only had success about 50% of the time when using oasis drains on nicu patients.They confirmed that their nursing staff has not been formally trained to use this system.No pictures or lot numbers were provided and the device was not returned for evaluation.The lot number was not provided so a review of the dhr and ncrs involving the lot could not be completed.No significant changes were made to the design of the device which would be likely to lead to this complaint.The ifu instructs the user not to use the drain if the device or packaging is damaged and to regularly check all connections.It provides detailed instructions for the setup and use of the drain.Complaint trending found that the actual occurrence level did not exceed the anticipated occurrence level.Only a single complaint of the reported defect was identified in the past 15 months.No excursions were identified.A complaint history review was completed which found one similar complaint in which the drain did not show an air leak despite the patient being confirmed to have a pneumothorax.In that complaint it was determined that the drain was used with an incompatible catheter.A recurring lot number report could not be completed without the lot number.A review of crs/capas found none related to this complaint.The complaint cannot be confirmed.A device nonconformity also cannot be confirmed.The most likely cause of this complaint was determined to be a use issue.The root-cause of this complaint is user error.The customer confirmed that the nursing staff was not trained to use this device.No evidence was identified to suggest that this complaint is related to design, manufacturing or instructions for use.

• Brand Name: DRAINS OASIS PEDI
• 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: 17214123
• Report Number: 3011175548-2023-00148
• Device Sequence Number: 6232631
• Product Code: KDQ
• UDI-Device Identifier: 00650862111019
• UDI-Public: 00650862111019
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 07/27/2023
• 2 Devices were Involved in the Event: 1 2

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: 3612-100
• Device Catalogue Number: 3612-100
• 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: 06/13/2023
• Supplement Date Received by Manufacturer: 07/05/2023; 07/25/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 07/06/2023; 07/27/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 8.5 FR PIGTAIL CHEST TUBE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 WK
• Patient Sex: Male
• Patient Weight: 3 KG