MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION DRAINS OASIS SINGLE; APPARATUS, AUTOTRANSFUSION

Model Number 3600-100

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2020

Event Type  malfunction  

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.

Event Description

The water seal didn't have water in it during an inspection while supporting a patient.They are unsure if it was tipped over.No patient injury.

Event Description

N/a.

Manufacturer Narrative

Upon removal of the returned chest drain from its packaging it was clear that there was water in the water seal.The drain was in good condition when received and still had plural fluid within the drain.When a chest drain is set up 45ml of water is to be filled through the suction port as indicated in the instructions for use.The returned drain exhibited the appropriate amount of water in the water seal chamber.It is not clear as to why the complainant was unaware of the fluid in water seal of the drain.A response received to a question asked indicated that the drain had been tipped over, and if this were the case the water would drain from the water seal chamber, but once the drain was placed upright the water would go back into the water seal chamber and the drain would function normally.In order to confirm the returned drain functioned properly the returned drain was disinfected and was set-up per the ifu and tested.An external vacuum of -80 mmhg was applied to the suction nozzle.The regulator was cycled from -10cmh2o to -40cmh2o and the output pressure verified.The regulator was regulating the vacuum pressure as expected and the drain was functioning appropriately.Based on the investigation results of the returned drain, the reported complaint of the water seal not containing water cannot be confirmed because the drain function appropriately.

• Brand Name: DRAINS OASIS SINGLE
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 10486384
• MDR Text Key: 206508995
• Report Number: 3011175548-2020-01098
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862110012
• UDI-Public: 00650862110012
• Combination Product (y/n): N
• PMA/PMN Number: K043140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR