MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION DRAINS OASIS SINGLE; APPARATUS, AUTOTRANSFUSION

Model Number 3600-100

Device Problem Infusion or Flow Problem (2964)

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

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.

Manufacturer Narrative

Analysis: the complaint details indicate that the fluid level once it reaches the 180ml graduation spills over to the next chamber instead of at the 200ml fluid level.Upon receipt of the drain it was disinfected as there was still fluid from the patient within the drain.There was hand written lines on the drain that were placed there by the staff monitoring the fluid level within the chamber.The highest line in the first chamber was at 190ml.If the fluid had been flowing over to the other chamber at 180ml it is not clear why a line was placed at the 190ml level of the collection chamber.To ensure the drain graduations were accurate.200ml of water that was dyed blue was measured in a separate laboratory beaker.The 200ml of fluid was then added to the first chamber to see if the fluid would spill over into the next chamber at 180ml as claimed by the institution.The result was that the drain chamber filled to the 196ml level and began to flow into the second chamber at this level.This was 4ml short of the 200ml level.The instructions for use specify the following in regards to graduation accuracy: ¿fluid level graduations are accurate within +/- 5% at capacity.¿ 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 when filled to the 200ml level spilled over into the next chamber at only 196ml and was within the acceptable graduation level as specified in the instructions for use atrium medical corporation cannot conclude that the device was faulty.

Event Description

N/a.

• 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: 8758000
• MDR Text Key: 150133668
• Report Number: 3011175548-2019-00738
• 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
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Date Manufacturer Received: 07/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1