MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION DRAINS MINI-EXPRESS; BOTTLE, COLLECTION, VACUUM

Model Number 16400

Device Problems Complete Blockage (1094); Defective Device (2588)

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

Event Type  malfunction  

Event Description

It was reported that during an in-service session they stated that when they used the lueralock syringe on the sample port-they were unable to extract sample."only bubbles occurred, with nothing being drawn into the syringe".A few days prior to this they were able to extract sample.

Manufacturer Narrative

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

Manufacturer Narrative

Correction section: h6 - medical device - problem code.Investigation: investigation: the complaint is in regards to a report received where the home patient or caregiver was no longer able to evacuate drainage from their express mini drains with a syringe.The luer port became clogged after repeated emptying.There was no reported patient harm associated with the event.The device was not returned for evaluation and the lot number was not provided for the complaint.Therefore, no device evaluation could be performed, nor is deemed necessary, given usage of the device outside of its intended use environment and a failure mode specific to this off-label usage.Despite no evidence of any product malfunction, the event is considered confirmed, as the complaint involved reported use error/off-label use.The capa search identified a historical capa request from post-market surveillance in regards to the observed increase in outpatient use of express mini 500 drains.Additionally, there have been several capa requests initiated from complaint trend excursions related to outpatient use.Capa 682612 for "mobile drainage products - outpatient use and continued use" identified that express mini 500 devices are being utilized in outpatient settings; however, home use is not the intended use environment.Aw011485 - ifu, drains, express mini 500, multilanguage (rev aa) does not state the device is for use in a clinical setting; it is implied in the ifu precaution section where it identifies the user.Additionally the cr evaluation suggests that there are instances of repeated fluid removal from the drain from the sampling port and continued reuse on the same patient, which does not align with the ifu as indicated in the precautions and sampling patient drainage sections.The root cause evaluation for the capa has determined that the usage of the express mini 500 devices is occurring because there is a clinical need for outpatient drainage systems.It was also determined that marketing materials were historically provided for express mini 500 suggesting that the device could be used in an outpatient setting and emptied, which does not align with the current design inputs.At the time of this complaint investigation, the capa is in the action planning phase.In terms of the reported malfunction, the express mini 500 drain is not designed or intended for fluid in the collection chamber to be emptied of fluid as a means to continue use of the device on a patient beyond 500 ml of fluid collection.The nac sample port is not designed or intended to be used as a means of draining fluid from the collection chamber of the device.Management of the device in the home setting being performed by non-clinical/non-medical personal individuals or by clinical care providers not familiar with management of a thoracic drain has the potential to increase the likelihood of malfunctions.Based on the evaluation, the root causes identified for the complaint investigation include design, labeling and user preference.A risk assessment was performed and found that the associated reported defect, the express mini 500 product remains operating within its approved risk profile.The risk management file adequately covers risk associated with outpatient and off-label usage.A further risk analysis of the outpatient use and continued use of the express mini 500 drains has been documented in hhe2022002.

Event Description

N/a.

• Brand Name: DRAINS MINI-EXPRESS
• 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: 14314464
• MDR Text Key: 291204358
• Report Number: 3011175548-2022-00139
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 00650862164008
• UDI-Public: 00650862164008
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K984496
• 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
• Report Date: 01/19/2023

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: 16400
• Device Catalogue Number: 16400
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/26/2022
• Initial Date FDA Received: 05/07/2022
• Supplement Dates Manufacturer Received: 01/12/2023
• Supplement Dates FDA Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.