MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION DRAINS OASIS SINGLE; BOTTLE, COLLECTION, VACUUM

Model Number 3600-100

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

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

Event Date 02/17/2022

Event Type  malfunction  

Event Description

Nurse educator called for information and troubleshooting for an oasis drain.She reported that the patient had the drain connected to a very small chest tube, but it was for drainage of a very thick empyema.The nurses had alerted her that the patient pressure float ball was at the +2 mark and there was no fluctuation.Troubleshooting revealed that the suction was appropriately set and the bellows was visible in the window.Pinching the suction tubing did not result in fluctuation in the suction chamber but the ball did return to the "0" mark.She acknowledges that the thick drainage had not accumulated any additional volume for several hours.She is quite sure that the drainage has plugged the tube and will discuss with her medical officer.She had no further questions.

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

Additional information: section h6.Investigation summary: a call was received by the getinge call center from an educator looking for help troubleshooting and for information about an oasis chest drain.She reported that the patient had the drain connected to a very small chest tube, but it was for drainage of a very thick empyema.The nurses had alerted her that the patient pressure float ball was at the +2 mark and there was no fluctuation.Troubleshooting revealed that the suction was appropriately set and the bellows was visible in the window.Pinching the suction tubing did not result in fluctuation in the suction chamber but the ball did drop.She acknowledges that the thick drainage had not accumulated any additional volume for several hours.She is quite sure that the drainage has plugged the tube and will discuss with her medical officer.She was pleased with the help and had no further questions.The complaint cannot be confirmed since the device or pictures could not be provided.A product lot number was not provided and the device in question was also not provided.However, if there was no flow through the chest tube inserted into the patient, this would explain why the float ball was not fluctuating or tidaling.The complaint history and capa searches did not reveal any details to aid in the investigation.Based on the details of the complaint the most likely root cause is that the chest tube catheter chosen was too small for proper drainage.The root cause has been assigned as user- operational context.The instructions for use at the time of the reported incident and the current instructions for use both specify that compatible thoracic catheters used should be between 24fr and 40fr for the oasis 3600 single drain.H3 other text : device not available for return.

• Brand Name: DRAINS OASIS SINGLE
• 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: 18681805
• MDR Text Key: 335944734
• Report Number: 3011175548-2024-00050
• Device Sequence Number: 1
• Product Code: KDQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K043140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

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: Health Professional
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2022
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: 04/17/2024
• Supplement Dates FDA Received: 04/18/2024
• 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