MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OASIS DRAIN, DRY SINGLE W/AC

Model Number 3600-100

Device Problem Decrease in Suction (1146)

Patient Problem No Information (3190)

Event Date 12/02/2016

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: 1219977-2016-00256.

Event Description

Report received stated that after connecting an oasis drain, suction was unable to be maintained even after closing chest and turning up wall suction.

Manufacturer Narrative

The returned unit was received, disinfected and then inspected for any visual damage.The drain was then set-up per the instruction for use (ifu) for functional testing.The returned device already had water added to the water seal/air leak monitor (alm) section of the drain.With suction control set at -20 cmh2o and the patient line clamped, the unit was attached to a suction source per standard ifu setup procedures above.The patient line was attached to a pressure measurement device and unclamped.The vacuum on the drain was set to -20 cmh2o and the read-out on the testing unit display was -19.69 cmh2o, which meets the product requirements of not more than -45 cmh2o and it is an appropriate reading for a -20 cmh2o setting.During the testing the drain functioned properly with no bubbling in the water seal indicating there was no leak in the drain.With the patient tube clamped there was no evidence of air leakage.This was determined by observing the air leak monitor (alm) section of the drain.Bubbling in the alm would indicate that there was an air leak in the drain body or patient tubing, this bubbling was not observed in the returned unit.Conclusion: the dhr review indicated no issues with the manufacture of the units.The returned units functioned to specification with adequate suction levels and no leakage.

• Brand Name: OASIS DRAIN, DRY SINGLE W/AC
• Type of Device: OASIS DRAIN, DRY SINGLE W/AC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH 03054 ; 6038645366
• MDR Report Key: 6170790
• MDR Text Key: 62258344
• Report Number: 1219977-2016-00255
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862110012
• UDI-Public: 00650862110012
• 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: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Expiration Date: 11/07/2019
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Device Lot Number: 245033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2016
• 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: 54 YR
• Patient Weight: 95