MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION DRAINS OCEAN DOUBLE; BOTTLE, COLLECTION, VACUUM

Model Number	2020-100
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	02/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
Attending physician called reporting an incident on a postsurgical patient.The nurses had attached a new chest drain because they discovered the collection chamber nearly full.It was discovered that they had used a dual collection drain but only attached one of the collection tubings.The second tubing was not clamped off.The lung collapsed.The physician reported that the patient is fine.He had questions regarding the design, and questioned why there isn¿t a plug supplied ¿ he did note the slide clamp.It was communicated that the setup instructions would have been supplied in the packaging and the dual drain is expected to be chosen when two patient tubes will be connected.He called this a ¿near miss¿ and suggested that the nurses require in servicing.
Additional Manufacturer Narrative
This complaint claims that an ocean double chest drain (p/n 2020-000) was used on a postsurgical patient with only a single tube connected.The description explains that the second tube was not connected and was also not clamped shut.The physician questioned why a plug was not supplied to seal off the unused tube, but confirmed that the clamp was present on the drain.The patient suffered a pneumothorax.Based on the details provided by the customer and the information reviewed during the investigation, it cannot be confirmed that the device was non-conforming to it's specifications.The complainant confirmed that the required components were present and suggested that the nursing staff operating the device may require more training (which was provided shortly after).The device was not used according to its instructions and the resulting hazardous situation and patient harm were both anticipated risks in the risk documentation for this device.The root-cause for this complaint is user error.A dhr could not be completed because the lot number was not provided.However, based on the description of the complaint, it is unlikely that any material, manufacturing, equipment, or labeling issues contributed to this event.The ifu for this device provides instructions for how to set up a dual collection drain using one or both of the patient tubes.These instructions were not followed, which is what caused the reported hazardous situation.Complaint trending and the complaint history review found no related complaints.A review of cars/capas/ncrs/scars found nothing related to this complaint.H3 other text: device not available for return.
Event or Problem Description
N/a.

• Brand Name: DRAINS OCEAN DOUBLE
• 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: 11490941
• Report Number: 3011175548-2021-00322
• Device Sequence Number: 3971746
• Product Code: KDQ
• UDI-Device Identifier: 00650862102048
• UDI-Public: 00650862102048
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K043582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2022

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
• Operator of Device: Health Professional
• Device Model Number: 2020-100
• Device Catalogue Number: 2020-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2021
• Supplement Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 08/23/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown