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

Model Number 3600-100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/12/2021

Event Type  Death  

Manufacturer Narrative

Follow-up report will be submitted upon completion of the investigation.

Event Description

Patient passed away because they needed another drain and the hospital staff took too long to locate one.There were only two drains left in the hospital because they were waiting on several orders from cardinal.

Manufacturer Narrative

The complaint details state: patient passed away because they needed another drain and the hospital staff took too long to locate one.There were only two drains left in the hospital because they are waiting on several orders from cardinal.Multiple attempts to obtain additional information regarding the event were made and no response was provided.No product has been returned and no lot number was provided.Based on the initial report and information available, there has been no allegation of an actual device nonconformance or malfunction.It is unknown why the patient required another drain or what drain was initially used.The complaint and root cause are unconfirmed.The event is attributed to lack of available inventory at the reporting facility.A trend analysis and risk review were performed.The product is operating within the approved risk profile.Per the medical assessment: after review of the details provided and considering the fact that ¿oasis¿ dry suction water seal chest drain, model # 3600-100 drain was on backorder, chest drain was never used on a patient and no any additional information is available for evaluation, one can infer that ¿oasis¿ dry suction water seal chest drain, model # 3600-100 was not the attributing factor to the patient¿s death.

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: 12530882
• MDR Text Key: 273286725
• Report Number: 3011175548-2021-01000
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Date Manufacturer Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Outcome(s): Death