MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION EXPRESS; EXPRESS II, SINGLE COLLECTION (EXPRESS DRY SEAL CHEST DRAIN)

Model Number 4000-100N

Device Problems Fluid/Blood Leak (1250); Defective Component (2292)

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

Event Date 02/16/2017

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

Report received stated that the nurse placed fluid in the air leak monitor (alm) but there was no water observed in the alm.The report also stated that the drains bellows were not working.

Manufacturer Narrative

Returned unit was examined and a stress mark was found in the lower left corner of the drain.A stress mark is indicative of shipping and handling damage.Due to the stresses that caused the stress mark, the cover separated from the body leaving a gap between the cover and body in the air leak monitor (alm) area.Fluid was introduced into the alm per the instructions for use (ifu).The fluid immediately leaked out of the alm due to the gap between the cover and body.The unit was tested for function and the bellows did indicate suction was applied.The suction level achieved was not at the -20 cmh2o that the unit was set at.This was due to the air leak allowed by the gap between the body and cover, allowing air to come into and negate some of the suction applied.The suction level applied by the user may have been less than the standard/recommended level used in lab testing.This could account for their observation that the bellows was not moving.A device history record review could not be performed since the lot number was not provided.Clinical evaluation: the product is protected by an outer box used for shipping and by protective packaging to prevent breakage.If the product box is damaged in shipment, this would likely be noticed on receipt of the product at the facility and the product would not be accepted.The instructions for use advise: "do not use if the package is opened or damaged." the device is supplied sterile and the packaging should be inspected prior to use to ensure it is intact and not damaged.If the product was presented in surgical theater the integrity of the packaging of a sterile device would be noticed prior to being introduced to the sterile field, would be rejected and therefore would not impact the patient.A second device would have to be located and prepared for use.This may represent a delay in therapy.

• Brand Name: EXPRESS
• Type of Device: EXPRESS II, SINGLE COLLECTION (EXPRESS DRY SEAL 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: 6356301
• MDR Text Key: 68603581
• Report Number: 1219977-2017-00031
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862115130
• UDI-Public: 00650862115130
• 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: 02/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 4000-100N
• Device Catalogue Number: 4000-100N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2017
• Initial Date FDA Received: 02/24/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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