MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION DRAINS OASIS SINGLE; APPARATUS, AUTOTRANSFUSION

Model Number 3600-100

Device Problem Material Integrity Problem (2978)

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

Event Date 03/23/2022

Event Type  malfunction  

Event Description

Report received stated that the chest tube on the drain was damaged.Customer was unsure how the damage occurred.They thought possibly that when the patient's bed was brought down from an elevated position during the night, it might have punctured a hole in the tube.Patient not affected it was resolved by changing to a new drain.

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.

Manufacturer Narrative

Additional information: d9.

Event Description

N/a.

Manufacturer Narrative

Customer reported that the strain relief tube (which connects the patient tube to the drain) was discovered with a hole in it after the drain had been used for some time.Pictures of the tube provided by the customer look like it was crushed.The reporter states that the patient's bed was lowered during the night and the damaged tube was discovered early in the morning, so it is probable that the tube was caught in the mechanism of the bed and was crushed.The tube was returned for evaluation.It was observed that the corrugated plastic around the tube is broken and torn.Some edges of the break are stretched, as if pulled apart with great force.The damage appears consistent with the proposed theory that the tube was caught in the mechanism of the bed as the bed was lowered.Based on the details provided by the customer and the information reviewed during the investigation, it was confirmed that the device was damaged, however, it was not confirmed that the damage occurred during manufacturing or shipment of the product.It was determined that the most probable cause of the damage is operational context.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 properly set up and operate the drain.Complaint trending and the complaint history review found no related complaints.A review of cars/capas/ncrs/scars found nothing related to this complaint.The hazardous situation/harm is addressed in the harm hazards analysis document which assigns it a severity level of 1.This was determined to be appropriate based on the harm that was reported in the complaint.Complaint trending concluded that the actual occurrence level matched the anticipated occurrence level and there was only a single occurrence within the reviewed trending periods.No excursions were identified in trending.

Event Description

N/a.

• Brand Name: DRAINS OASIS SINGLE
• Type of Device: APPARATUS, AUTOTRANSFUSION
• 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: 14051134
• MDR Text Key: 288862485
• Report Number: 3011175548-2022-00119
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862110012
• UDI-Public: 00650862110012
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2022

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?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 03/29/2022
• Initial Date FDA Received: 04/08/2022
• Supplement Dates Manufacturer Received: 05/27/2022; 09/15/2022
• Supplement Dates FDA Received: 05/27/2022; 09/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Sex: Male