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

Model Number 3600-100

Device Problems Connection Problem (2900); Material Deformation (2976)

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

Event Date 07/14/2022

Event Type  malfunction  

Event Description

Received an fda voluntary medwatch report (mw5110940).Report received stated that the "soft plastic squeeze syringe filled with sterile water provided to inject the sterile water into the atrium has a soft plastic tip that you insert into the atrium.Upon attempting to insert the tip of the soft syringe, the tip would collapse and not be able to be inserted.

Manufacturer Narrative

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

Manufacturer Narrative

Investigation: this complaint claims that when attempting to insert the plastic tip of the water ampoule into the drain to inject sterile water into the water seal chamber, the tip of the ampoule collapsed and could not be inserted.The described plastic squeeze syringe that is described in the instructions for use as a water ampule was returned for evaluation.The water ampule was in good condition and the sterile water within the ampule was not present as the twist off tip had been removed and is normal for a water ampule that has been used.The tip itself was in good condition and not bent, cracked or damaged in any way.Neither the drain device nor pictures were provided, only the ampule was returned, so the complaint could not be confirmed.In addition, the information provided by the customer indicated that the device was not set up properly, as they attempted to fill the water seal chamber using the incorrect port.It would appear that the water ampoule was attempted to be used at the bottom of the drain in the back that was not intended for the water ampoule to be utilized.The instructions are very clear in this regard.The ifu instructs the user not to use the drain if the device or packaging is damaged.It instructs the user to fill the water seal chamber by adding the water through the suction nozzle on the top of the drain.It also identified the access port on the back of the water seal chamber as one to be used to adjust the water level using a 19 gauge needle and syringe.There is also a iconographic ifu included on the back of each drain which clearly shows where to add the water.The lot number was not provided so a dhr review could not be performed.The information provided by the customer indicates that this issue is not related to materials, equipment, or manufacturing procedures.Complaint trending found that the actual occurrence level did not exceed the anticipated occurrence level.No excursions were identified.A complaint history review was completed which found no related complaints.A recurring lot number report could not be completed because the lot number was not provided.Each drain is also packaged with an iconographic ifu which provides clear visual instructions for where to add the sterile water.A review of cars/capas found no related cars or capas.The root-cause of this complaint was determined to be user error.

• 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: 15163347
• MDR Text Key: 303134900
• Report Number: 3011175548-2022-00217
• 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: Other,Health Professional,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1