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

Model Number 3600-100

Device Problem Output Problem (3005)

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

Event Date 06/05/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the chest tube drainage system may have a discrepancy in regards to drainage.It was noted that the drainage from the chest tube stops at 180cc and then dumps over into the next chamber, leaving a void of 20cc (between 180-200).This gives an inaccurate account of the amount of drainage as the nurse looking at the system may record an output of 210 or greater when it is actually less because there was not drainage noted in the space/area between 180 and 200.

Manufacturer Narrative

Analysis: the complaint details indicate that on reaching the 180 ml graduation in the drainage chamber, the fluid level spills over to the next chamber instead of reaching the 200 ml graduation.As the drain in question was not returned.Atrium medical corporation cannot confirm the complaint.As the lot number of the drain was not provided a review of the device history records could not be performed.Conclusion: as the chest drain in question was not returned atrium medical corporation cannot determine that the oasis chest drain was faulty.

• Brand Name: OASIS SINGLE CHEST DRAIN SYSTEM
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 8756318
• MDR Text Key: 149943919
• Report Number: 3011175548-2019-00736
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/02/2019

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 Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2019
• Initial Date FDA Received: 07/02/2019
• Supplement Dates Manufacturer Received: 07/06/2019
• Supplement Dates FDA Received: 07/19/2019
• 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