MAUDE Adverse Event Report: ATRIUM MEDICAL OCEAN ATS BLOOD RECOVERY DRAIN; APPARATUS, AUTOTRANSFUSION

Model Number 2050-000

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/20/2018

Event Type  malfunction  

Manufacturer Narrative

We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.

Event Description

Report received stated that upon opening a packaged ocean ats blood recovery drain it was found that the incorrect drain was in the package.The package contained an ocean single drain.

Manufacturer Narrative

The unit was no returned for evaluation.A review of the device history records for this lot of chest drains was conducted to ensure there were no discrepancies during the time of manufacture.The review concluded that there were no discrepancies related to the complaint during the manufacture of the chest drains.All labels were accounted for and reconciled.Several attempts were made to obtain additional information without any success.Without further details atrium cannot determine if the product was packaged incorrectly.The process of manufacturing conducts a full line clearance prior to beginning a new lot of chest drains as well as label verification.The printing process at the time of manufacture requires the total breakdown of the printing ink and silk screens as the color of the 2050-000 is red and the color of the 2002-000 is blue a complete changeover would have needed to be conducted.Atrium chest drainage systems are indicated for the evacuation of air and/or fluid from the chest cavity or mediastinum and to help re-establish lung expansion and restore breathing dynamics.When a product is introduced during a procedure the standard of care is that two clinicians confirm correct product, correct size and expiration date prior to introduction to the sterile field.

• Brand Name: OCEAN ATS BLOOD RECOVERY DRAIN
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 7422629
• MDR Text Key: 105522814
• Report Number: 3011175548-2018-00357
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• PMA/PMN Number: K043582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2018

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: 01/05/2020
• Device Model Number: 2050-000
• Device Catalogue Number: 2050-000
• Device Lot Number: 247006
• Other Device ID Number: 00650862103014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2018
• Initial Date FDA Received: 04/11/2018
• Supplement Dates Manufacturer Received: 04/19/2018
• Supplement Dates FDA Received: 04/26/2018
• Date Device Manufactured: 01/12/2017
• 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