MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OASIS PEDIACTIC CHEST DRAIN

Model Number 3612-100

Device Problem Air Leak (1008)

Patient Problem No Information (3190)

Event Date 09/07/2015

Event Type  Injury  

Manufacturer Narrative

We will submit the follow-up report once the evaluation is completed.

Event Description

Customer had an infant/pediatric chest drainage issue.Per the nurse, the chest tube was attached to the patient and it showed an air leak in chamber.They replaced it with a new unit and air leak went away.

Manufacturer Narrative

The drain was disinfected per standard operating procedures.The drain tubing was inspected and no holes were found.The connector o-ring was present.The drain was setup per instruction for use (ifu) setup procedures and tested.The drain functioned as designed.The patient tube was clamped off at the patient end and no air leaks were noted in the water seal/air leak monitor.Conclusion: the returned drain was fully functional with no leakage.The root cause may have been a poor connection to the catheter or a misplaced catheter allowing air to get into a drainage hole.

• Brand Name: OASIS PEDIACTIC CHEST DRAIN
• Type of Device: OASIS PEDIACTIC CHEST DRAIN
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH 03054 ; 6038645366
• MDR Report Key: 5131410
• MDR Text Key: 27768728
• Report Number: 1219977-2015-00287
• 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: company representative,distri
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/17/2015

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: 3612-100
• Device Catalogue Number: 3612-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/07/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 MO
• Patient Weight: 3