MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OASIS DRAIN, DRY PEDIATRIC

Model Number	3612-400
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.Related mdr's: 1219977-2016-00139 and 1219977-2016-00141.
Event or Problem Description
Report received stated that an oasis drain would not evacuate air when connected to the patient.The bellows appeared not to completely expand to the indicator mark or beyond as stated in the instructions for use (ifu).Another chest tube and drain from a different lot was used without any issues.
Additional Manufacturer Narrative
Engineering analysis: the specific units from the complaint were not returned for evaluation.Six (6) units from the same lot of drains (232463) were pulled from stock and tested for bellows function.Units were set up per instructions for use (ifu) and with a setting of (80 mmhg suction level).All the bellows extended past the indicator under vacuum, but some of the bellows were extended at an angle.This is an indication that suction was adequately provided, as intended by device design.The angled bellows in no way affects the function of the device.The bellows is only an indicator of applied suction and does not affect the function of the device.Engineering summary/conclusion: the root cause was faulty interpretation of the bellows function by the user.Extension of the bellows indicates suction is applied to the device and patient.

• Brand Name: OASIS DRAIN, DRY PEDIATRIC
• Common Device Name: OASIS DRAIN, DRY PEDIATRIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• MDR Report Key: 5774260
• Report Number: 1219977-2016-00140
• Device Sequence Number: 623159
• Product Code: CAC
• UDI-Device Identifier: 00650862111026
• UDI-Public: 00650862111026
• 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: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2016

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: Physician
• Device Expiration Date: 01/05/2019
• Device Model Number: 3612-400
• Device Catalogue Number: 3612-400
• Device Lot Number: 232463
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/06/2016
• Supplement Report FDA Received Date: 07/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 2 DA
• Patient Weight: 1