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

Model Number 3600-100

Device Problems Off-Label Use (1494); Obstruction of Flow (2423)

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

Event Date 12/13/2021

Event Type  malfunction  

Event Description

Received call from spouse on behalf of his wife who was sent home from the hospital after surgery with an oasis chest drain.He stated that the drainage was not draining from the tube into the drainage collection chamber.He sent me a picture which showed a dependent loop and the tubing on the floor.I asked him to coil the tubing above the drain to allow gravity to drain the fluid into the chamber which successfully resolved the problem.He asked multiple other questions related to patient care.I let him know i was only able to discuss drain function issues and suggested he reach out to their home health nurse for assistance.

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

Investigation summary: reason for call: drainage problem equipment/catheter: oasis chest drain report received call from husband on behalf of his wife who was sent home from the hospital after surgery with an oasis chest drain.He stated that the drainage was not draining from the tube into the drainage collection chamber.He the emergency support team representative a picture which showed a dependent loop and the tubing on the floor.The support representative asked him to coil the tubing above the drain to allow gravity to drain the fluid into the chamber which successfully resolved the problem.The caller asked multiple other questions related to patient care; the support representative let him know she was only able to discuss drain function issues and suggested he reach out to their home health nurse for assistance.The drain in question was an oasis drain catalogue number 3600-100.This is a full-size model drain and is not intended to be used in a home setting and is not marketed as a mobile device.Based on the details provided, the complaint cannot be confirmed to be the fault of the device.There is no assertion of an adverse event associated with the use of this chest drain.Dependent loops are to be avoided if fluid drainage is present.The drainage that was not flowing into the drain, and the issue was resolved by simply lifting the tube set above the height of the drain.The complaint details do mention that the date of event was 13 dec 2021.This is at a time period when covid 19 was very much still prevalent, and it is plausible that the physician made a discretionary decision to send a patient home with the full-size drain.A device history record could not be performed as the lot number of the chest drain used was not provided with the complaint.A review of the current instructions for use aw012004 revision aa in the precautions section states: 8.Users should be familiar with thoracic surgical procedures and techniques before using a chest drain.¿ there is no specific warning or caution within the instructions for use regarding home use of the chest drain.At the time of use the instructions for use was part number aw011482 ifu oasis revision aa.This ifu was also reviewed and has the same precautions as seen in ifu aw012004.A risk review found that the risk management documents for this product adequately address the reported defect and the severity and anticipated occurrence level are appropriate.Based on the details of the complaint and investigation results, the complaint is considered a use error and confirmed, but there was no confirmed drain non-conformity and no described adverse event.However, the investigation has identified that the labeling, specifically the instructions for use do not indicate that the product is only to be used in a clinical setting.In this regard the root cause may be considered design-labeling and use error.The complaint will be escalated to a capa request (989042) as there is a potential labeling issue as the instructions for use do not mention that the drain is only intended to be used in a clinical setting.H3 other text : device not available for return.

Event Description

N/a.

• 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: 18681811
• MDR Text Key: 335213939
• Report Number: 3011175548-2024-00048
• Device Sequence Number: 1
• Product Code: KDQ
• 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: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

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
• Initial Date Manufacturer Received: 12/13/2021
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: 03/21/2024
• Supplement Dates FDA Received: 03/24/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female