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

Model Number 3612-400

Device Problems Insufficient Flow or Under Infusion (2182); Device Operates Differently Than Expected (2913); Activation Failure (3270)

Patient Problem No Information (3190)

Event Date 06/11/2016

Event Type  Injury  

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: 1219977-2016-00140, 1219977-2016-00141.

Event 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.

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
• Type of Device: OASIS DRAIN, DRY PEDIATRIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drvie; hudson NH 03051
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH 03054 ; 6038645366
• MDR Report Key: 5774254
• MDR Text Key: 48922197
• Report Number: 1219977-2016-00139
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862111026
• UDI-Public: 00650862111026
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2016
• Initial Date FDA Received: 07/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 2 DA
• Patient Weight: 1