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

Model Number 3600-100

Device Problem Insufficient Information (3190)

Patient Problem Cardiac Arrest (1762)

Event Date 04/19/2019

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted upon the completion of the investigation into this event.

Event Description

Hospital reported that blood backed up into the wall suction during cardiac arrest.

Manufacturer Narrative

The complaint details indicate that the fluid within the drain backed up into the wall during a cardiac arrest.If the fluid within the drain exceeded the drain volume the fluid will continue up the vacuum line to the vacuum source if not checked regularly.Some institutions have fluid collection canisters to protect their vacuum source in line just prior to the wall regulator as added protection.The instructions for use specify to check the drains regularly.Summary - based on the results of the investigation atrium medical cannot conclude that there was any issue with the drain in question.The drain must be checked regularly to ensure proper operation as identified in the instructions for use.

• Brand Name: OASIS DRAIN
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 8566808
• MDR Text Key: 143656606
• Report Number: 3011175548-2019-00487
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/30/2019

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: Health Professional
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Initial Date Manufacturer Received: 04/19/2019
• Initial Date FDA Received: 04/30/2019
• Supplement Dates Manufacturer Received: 05/15/2019
• Supplement Dates FDA Received: 05/17/2019
• Was Device Evaluated by Manufacturer?: No
• 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