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

Device Problems Use of Device Problem (1670); Suction Failure (4039); Unclear Information (4052)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/22/2021

Event Type  malfunction  

Event Description

Hospital rn called reporting they had just received a patient from another facility and had switched the patients drain to an atrium ocean.She was concerned as there was only bubbling in chamber c and none in chamber a when attached to suction.After some extensive troubleshooting the actual chest tube catheter was determined to be the cause at the insertion site.She and her team adjusted and redressed.Drain was functioning as expected at this time.

Manufacturer Narrative

This mdr is being submitted as part of a retrospective review.During activities being performed for capa 682612 (associated with express mini 500 continued use and use of devices outside of the healthcare setting), atrium medical corp.Became aware of calls received by the getinge emergency support program (esp) team that were not logged as complaints.A retrospective review of the calls logs has resulted in the identification of this complaint/mdr.Upon completion of the investigation into this event a follow up report will be submitted.

Manufacturer Narrative

A call was received from a rn with questions regarding the function of an ocean drain.She noted that there was bubbling in chamber c and none in a when the drain was attached to suction.After some extensive troubleshooting the actual chest tube catheter was determined to be the cause due to a leak at the insertion site.The nurse and her team adjusted the catheter and redressed the patient.The drain was then functioning as expected.Several follow up calls and texts were placed to verify functionality of the drain.Based on the outcome of the above call details the cause of the bubbling as described was related to the chest tube at the location of the insertion site.As the location of the leak was not within the drain or a result of the drain in use, neither the complaint nor a nonconformance with the device can be confirmed.No lot number was provided, and the chest drain in question was not returned.No companion or contemporaneous sample evaluation is required as there was no deficiency with the drain noted per the call information.A review of complaint history, capa/cr history, and complaint trending was performed.There were no similar incidents identified where the cause of a leak was due to the placement of the catheter within the patient.A lot number was not provided so a dhr review and recurring lot number search could not be performed.The information provided by the caller indicated the cause of the leak was the catheter and was not a fault of the drain, thus an ncr and scar review were not performed as there is no potential identified for a device nonconformance.Based on the details of the complaint and investigation results, the complaint has not been confirmed to be the fault of the product as the caller identified that the leak was at the location where the chest tube entered the patient.An adverse trend has not been identified for the assigned hazardous situation/harm for this product family.There is no device malfunction noted and therefore the root cause is user anticipated procedural complication.Device not available for return.

• Brand Name: OCEAN DRAIN
• Type of Device: 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: 18681120
• MDR Text Key: 335561449
• Report Number: 3011175548-2024-00028
• Device Sequence Number: 1
• Product Code: KDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose