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

Model Number 3600-100

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

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 the fluid level once it reaches the 180ml graduation spills over to the next chamber at this point instead of the 200ml fluid level.As the drain in question was not returned atrium medical corporation cannot confirm the complaint.If the drain had been returned the investigation would have been able to fill the chamber to the 200ml graduation to ensure the fluid was not spilling over into the other chambers prior to reaching the 200ml mark.As the lot number of the drain was not provided a review of the device history records could not be performed.Atrium medical corporation only releases product that has passed all quality and performance requirements.Every drain that is produced is 100% pressure tested in manufacturing to ensure there are no leaks.Conclusion: as the chest drain in question was not returned atrium medical corporation cannot confirm that the oasis chest drain was faulty.H3 other text : not returned.

Event Description

N/a.

• Brand Name: OASIS SINGLE DRAIN
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8697584
• MDR Text Key: 148273562
• Report Number: 3011175548-2019-00677
• 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: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• 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?: No
• Date Manufacturer Received: 06/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other