MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OASIS; DRAIN, DRY SINGLE W/AC

Model Number 3600-100

Device Problem Crack (1135)

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

Event Date 10/06/2017

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

Reported received stated that the drain was noticed to be cracked.No further information was provided.

Manufacturer Narrative

The unit was received and inspected.The front plate or face of the drain had been cracked and partially separated from the main body at the top right corner as there was visible space between the welded joint.The drain face had been marked with a black marker.The marking indicated the fill level was at 500ml.This gap or breach in the sealed unit would cause the air leak monitor to exhibit extreme bubbling indicating that there was an air leak.A full review of the device history records of this production lot of drains could not be conducted as the product lot number was not provided.If the lot number were provided the records would have shown that this lot of chest drains passed all quality and performance inspection requirements.The investigation was able to confirm that the chest drain most likely had become damaged after leaving the atrium manufacturing facility.It is not known at what point the drain became damaged.In some cases we have learned that if the chest drain was stationed on the floor below the patient, when the bed is lowered it can sometimes make contact with the drain damaging it.In this case that scenario cannot be confirmed.Clinical evaluation: the oasis chest drain is indicated for 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 facilitates post-operative collection and re-infusion of autologous blood from the patient's pleural cavity or mediastinal area.Damaged packaging may be the result of improper storage conditions or shipping occurrences.The instructions for use (ifu) states in precautions: do not use if device or packaging is damaged.

• Brand Name: OASIS
• Type of Device: DRAIN, DRY SINGLE W/AC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd.; merrimack NH 03054
• Manufacturer Contact: lori gosslein ; 5 wentworth drive; hudson, NH 03051 ; 6038645366
• MDR Report Key: 6960455
• MDR Text Key: 90663751
• Report Number: 3011175548-2017-00187
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862110012
• UDI-Public: 00650862110012
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/18/2017

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: Other
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/06/2017
• Initial Date FDA Received: 10/18/2017
• Supplement Dates Manufacturer Received: 11/06/2017
• Supplement Dates FDA Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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