MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION EXPRESS; BOTTLE, COLLECTION, VACUUM

Model Number	16400
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The most common complaints associated with express mini 500 (p/n 16400) devices are those related to outpatient and improper use of the device.In outpatient cases, the drain is set up on a patient by a clinician and then that patient is sent home with the drain where they are then responsible for its use and interpretation.This puts the responsibility of using the drain on a person who is not necessarily a trained medical professional with any knowledge of how to use and interpret the device.Sampling port clogged: this typically occurs when the user attempts to empty the drain with a syringe through the sampling (luer) port in order to extend the use of the drain.This can lead to collected fluid becoming trapped in the sampling port and solidifying, preventing future use of the port.This port is intended for clinicians to take samples of the drain fluid, not for routinely removing large amounts of fluid in order to extend the use of the drain.The ifu instructs the user to replace the drain when it becomes full.It also states that the use of the luer port is intended only for sampling patient drainage and that the user should not use the port or any other means to attempt to empty fluid from the collection chamber.In addition to the instructions described for each type of complaint, the ifu states that "the express mini 500 is restricted for use in a healthcare facility.The express mini 500 should not be used for outpatient drainage." this type of complaint has been thoroughly investigated and is known to be cause by user error so further dhr review is not required to understand the issue.The ifu provides adequate instructions for the setup and use of the drain, as well as instructions about the intended users and environments.Outpatient and user error complaints of express mini 500 devices are confirmed.Device nonconformances are not confirmed for these issues.The root cause of these complaints is user error.Escalation determination: outpatient and improper use complaints of express mini 500 are attributed to user error which is currently being handled by the capa process.Trend review of these devices is completed on a monthly basis and excursions related to trending is also handled by the capa process.
Event or Problem Description
Report received from a patient¿s wife regarding her husband¿s atrium express mini chest drain during use.She stated that her husband was recently discharged home post-cardiothoracic surgery with an atrium express mini chest drain in place.Upon her husband's discharge from the hospital they were each educated by the nursing staff on how to drain fluid as it collected in the express drain.They were told to use a 10cc syringe (provided by the hospital) to remove fluid from the luer lock fluid sampling port.She stated that removal of fluid had been successful up until calling the 800 line.She was informed during the call that the usage of this drain at home is considered off-label, and instructions for removing fluid from the drain could not be provided.It was explained to her that the reason she was unable to remove fluid was likely due to the buildup of fibrin causing the leur port to clot off which would render her unable to pull any fluid from it.She reported that she tried instilling water into the drain to try to ¿loosen up¿ the sampling port.I recommended that she not attempt to pull any more fluid or troubleshoot at home any further.I reviewed that per getinge's ifu, the express mini should be switched out completely for a new drain once it becomes full of fluid versus using a syringe to remove it.It was recommended that if there were any further concerns regarding the drain, they should go to the nearest emergency room or reach out the physician¿s office to have the drain replaced.

• Brand Name: EXPRESS
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 22552173
• Report Number: 3011175548-2025-000007
• Device Sequence Number: 13098351
• Product Code: KDQ
• UDI-Device Identifier: 00650862164008
• UDI-Public: (01)00650862164008
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K984496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2025

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
• Operator of Device: Lay User/Patient
• Device Model Number: 16400
• Device Catalogue Number: 16400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 07/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LUER LOCK SYRINGE
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 77 KG