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 08/28/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Drain was opened, the fluid was placed in the suction port as stated in the instructions for use (ifu).The fluid leaked onto the floor.The drain housing was not completely sealed together.No harm to patient.

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

An evaluation of the returned chest drain was conducted.The claim was that "the fluid was placed in the suction port as per the instruction for use (ifu) and the fluid leaked onto the floor.The drain housing was not completely sealed together.Upon inspection, it was clear that the drain had either been dropped or damaged during or after transit.The drain in the lower left hand corner where the water seal is located had a white stress line and a raised section of the drain housing indicative of a drain that was dropped on it¿s edge.Fluid was filled into the water seal chamber and leaked out rapidly.This is considered a gross leak.A gross leak of this size would have easily been detected during the 100% leak check that is conducted to ensure the integrity of the vibration welds.A drain that does not pass this test is scrapped in process.It is noteworthy that drains are bulk packaged six to a box.A review of the customer complaint log going back two full years indicates that there have been no other reported leaks associated with this lot of oasis chest drains.A review of the device history records indicated that there were no non-conformances noted during the manufacture of this lot of oasis chest drains.Based on the details provided and the results of the investigation it cannot be concluded that the device in question was damaged during the process of manufacture.The damage to the drain is indicative of a drain that was either dropped once received by the institution or damaged during shipment.

• 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: 10517935
• MDR Text Key: 207379721
• Report Number: 3011175548-2020-01131
• 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: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2023
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Device Lot Number: 458632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 09/10/2020; 09/21/2020; 01/24/2021
• Supplement Dates FDA Received: 09/11/2020; 09/26/2020; 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 49