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

Model Number 3600-100

Device Problem Backflow (1064)

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

Event Date 01/31/2023

Event Type  malfunction  

Manufacturer Narrative

Upon completion of the investigation into this event a follow up report will be submitted.

Event Description

A drain was placed on the patient and when moving the patient from the surgical table to the bed, the blood that was in the reservoir went into the water seal.There was a need to exchange the drain.Without injury to the patient.

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

Investigation: this report claims that while moving a patient from the surgical table to bed, blood from the collection chamber of an oasis single drain (p/n 3600-100) got into the water seal chamber and the user had to exchange the drain.No harm was done to the patient.The device was not returned for evaluation and no pictures were provided.Several attempts were made to acquire additional information from the complainant, but they would not provide that information.The positioning of the drain while the patient was on the surgical table and while being transferred to the bed is not known.It is not known if the floor stand or the hangers were in use.It is not known if the drain remained upright at all times.It is not known how much fluid was in the collection chamber.It is not known if the drain sustained any sort of impact during the transfer.A dhr review was completed which found no anomalies in the manufacturing process.No ncrs involving this lot were identified.The incoming inspection records for the drain body subassemblies and the drain covers used in this lot were reviewed and no anomalies were identified.Relevant manufacturing procedures and device/part specifications were reviewed and no changes or inadequacies were identified which would likely contribute to this complaint.The ifu provides adequate instructions for the setup and use of the device and contains all the information required to avoid this failure.No changes are needed to the ifu.Complaint trending found that the actual occurrence level did not exceed the anticipated occurrence level.A complaint history review was completed which found one similar complaint of fluid potentially moving between chambers.The investigation for that complaint could not confirm a nonconformity and concluded that the most likely cause was a knockover.A recurring lot number report was completed which found no other complaints involving lot 478366.Because the device was not returned and no images or any other evidence of the incident was provided, this complaint cannot be confirmed.A device nonconformity cannot be confirmed with the provided information or with the information reviewed in this investigation.No evidence could be found that this complaint is related to the manufacturing of the device.The most likely cause of this complaint is that the drain was tipped during movement of the patient.The root-cause is operational context.H3 other text: device not returned.

• 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: 16387925
• MDR Text Key: 309952843
• Report Number: 3011175548-2023-00061
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 00650862110012
• UDI-Public: 00650862110012
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/06/2023

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
• Device Lot Number: 478366
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2023
• Initial Date FDA Received: 02/16/2023
• Supplement Dates Manufacturer Received: 02/23/2023; 04/05/2023
• Supplement Dates FDA Received: 03/03/2023; 04/06/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/16/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Male