MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OASIS; DRAIN, DRY SINGLE W/AC

Model Number 3600-100

Device Problem Connection Problem (2900)

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

Event Date 10/03/2017

Event Type  malfunction  

Manufacturer Narrative

We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.

Event Description

Received phone call from (b)(6) hospital that they had an oasis drain 3600-100 that upon changing the patient to a new drain and attaching the suction tube, they noticed that the suction port was loose and not attached to the drain.

Manufacturer Narrative

(medwatch uf (b)(4)).The returned unit was received and inspected.It was observed that the blue vacuum nozzle was not welded in place and floating in the box that it was returned in.The nozzle was inspected and showed no signs that it had been welded.The orifice that the nozzle goes into also showed no sign of being welded.A review of the preventative maintenance was conducted as well as the calibration status and the equipment was performing properly at the time of manufacture.The investigation was able to confirm that the nozzle was not welded.The manufacturing procedure for the drain nozzle weld station assembly instructs the operator to visibly inspect the weld for flash.There is reject and accept criteria provided within the procedure, however there are instances where there is no flash but the nozzle is still welded.The drains also goes through weld verification testing based on an acceptable quality level (aql) sampling plan.A full review of the device history records indicates that the device lot in question was manufactured properly and that there were no non-conformances noted during the manufacture of the product.Clinical evaluation: the oasis chest drain system is indicated for the evacuation of air and/or fluid from the chest cavity or mediastinum and to help re-establish lung expansion and restore breathing dynamics.It also may be used to facilitate postoperative collection and reinfusion of autologous blood from the patient's pleural cavity or mediastinal area.The instructions for use (ifu) advise to replace the chest drain if damaged or when collection volume meets or exceeds maximum capacity and to not use if device or package is damaged.(b)(4).

Event Description

Medwatch received from the user facility.

• Brand Name: OASIS
• Type of Device: DRAIN, DRY SINGLE W/AC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd.; merrimack NH 03054
• Manufacturer Contact: lori gosselin ; 40 continental blvd.; merrimack, NH 03054 ; 6038645366
• MDR Report Key: 6960454
• MDR Text Key: 90655844
• Report Number: 3011175548-2017-00184
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862110012
• UDI-Public: 00650862110012
• 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,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 09/01/2020
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Device Lot Number: 419857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1