MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. OASIS DRY SUCTION WATER SEAL CHEST DRAIN; APPARATUS AUTOTRANSFUSION

Model Number 3600-100

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2014

Event Type  Injury  

Event Description

Report received that a patient arrived to the critical care unit (ccu) from the post-anesthesia care unit (pacu) with a left chest tube x 2 and one chest drain.A new chest drain was set-up and when it was changed out an air leak was noticed.No patient harm.

Manufacturer Narrative

Upon completion of the investigation into this event a follow-up report shall be submitted.

• Brand Name: OASIS DRY SUCTION WATER SEAL CHEST DRAIN
• Type of Device: APPARATUS AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH 03051
• Manufacturer Contact: theresa morin ; 5 wentworth dr.; hudson, NH 03051 ; 5038801433
• MDR Report Key: 4241106
• MDR Text Key: 5015807
• Report Number: 1219977-2014-00369
• Device Sequence Number: 1
• Product Code: CAC
• 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: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 10/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR