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

Model Number 3600-100

Device Problem Break (1069)

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

Event Date 11/10/2017

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

Complaint received stated that a chest drain that was hooked to a patient was found to have a component inside the drain that was crushed.

Manufacturer Narrative

The unit was received and inspected.The original packaging materials that protect the drain were not provided.The suction/vacuum port of the drain was completely crushed and the main drain body was also badly damaged.The handle of the drain was also slightly bent.For this amount of damage there would have been a tremendous amount of force seen at some point after the drain left the atrium medical facility.Damage as egregious as this would have been identified in the process of manufacture and during quality control inspections.The device history records for the lot were reviewed and found to have met all specifications.It is unknown what type of transit and storage conditions the product saw after leaving atrium medical.There is no way to determine when the product was actually damaged whether it was possibly during shipping or related to handling/storage conditions, therefore the exact root cause cannot be determined.Clinical evaluation: the oasis chest drain system is 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.It also may be used to facilitate postoperative collection and reinfusion of autologous blood from the patient's pleural cavity or mediastinal area.The instructions for use (ifu) advise to replace the chest drain if damaged or when collection volume meets or exceeds maximum capacity and to not use if device or package is damaged.

• Brand Name: OASIS 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: 7064610
• MDR Text Key: 93819478
• Report Number: 3011175548-2017-00310
• Device Sequence Number: 1
• Product Code: CAC
• 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,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/28/2017

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: 09/08/2020
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Device Lot Number: 420399
• Other Device ID Number: 00650862110012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/10/2017
• Initial Date FDA Received: 11/28/2017
• Supplement Dates Manufacturer Received: 12/01/2017
• Supplement Dates FDA Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2015
• 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