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

Model Number 3600

Device Problems Improper Device Output (2953); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Pleural Effusion (2010)

Event Date 08/12/2015

Event Type  malfunction  

Event Description

A left pleural 10f pigtail catheter was inserted and was hooked up to chest tube drainage system.The system appeared to be working and was hooked up to -20 wall suction at the end of the procedure.Twenty-eight minutes later, the rn did an assessment and checked the drainage system and it was working with the lung appearing green and green pop up at the top of the kit.Two chest x rays were done about an hour later.The md came in the room 15 minutes later to check the patient and the set up as the patient's lung did not appear to be re-expanded on the x-rays.The chest tube insertion site, tubing and pleurvac were all checked at this point by the md and rn.The insertion site was covered with an occlusive dressing with no subcutaneous air at that time.The pigtail and chest tube tubing had no air leak present.The suction setup was pulling suction.The chest tube pleurvac had a green lung present but the pop up was no longer popped up green.Md felt that the pleurvac was not working appropriately and asked that a new chest tube drainage kit be set up.New drainage kit was applied and patient immediately had 20 cc serosanguinous drainage and both the green lung and green pop up were present.A new x-ray was ordered.Fifteen minutes later, a new chest x- ray was done.Ten minutes later, the md notified the rn that the pt's lung appeared re-expanded on the new x-ray.

• Brand Name: OASIS
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• MDR Report Key: 5147786
• MDR Text Key: 28239197
• Report Number: 5147786
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 3600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2015
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: UTD
• Patient Outcome(s): Other
• Patient Age: 34 YR
• Patient Weight: 48