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

Model Number 16400

Device Problems Off-Label Use (1494); Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930)

Event Type  Injury  

Event Description

It was reported a patient that was discharged with mini-atrium developed an infection and was readmitted.

Manufacturer Narrative

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

Manufacturer Narrative

Related mdr¿s: 3011175548-2022-00130.Investigation: the complaint stated that the reporting hospital staff had two patients who had express mini 500 drains at home and were readmitted to the hospital because of infection development.The span and location of infection is unknown.The hospital did not attribute infection development to the express mini 500 drains.The nurse educator asked for additional patient education material as part of infection evaluation process, since they are looking at all opportunities for improvement.The hospital did not report any adverse patient effects as a result of this event.The most likely scenario is that the infection occurred at the insertion site, but this is not confirmed.It is unknown what thoracic catheters were used with the drain.Infection is a recognized adverse event associated with the use of drains and is noted in the instructions for use.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 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 adverse event observed, 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 and anticipated complications observed in the associated complaints.Based on these evaluations, the root causes identified for this parent complaint investigation include design, labeling, anticipated procedural complications, 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, and recognizes infection as an anticipated complication.A further risk analysis of the outpatient use and continued use of the express mini 500 drains has been documented in (b)(4).H3 other text : device not available for return.

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: 14194441
• MDR Text Key: 289981208
• Report Number: 3011175548-2022-00129
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 16400
• Device Catalogue Number: 16400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2022
• Initial Date FDA Received: 04/25/2022
• Supplement Dates Manufacturer Received: 01/12/2023
• Supplement Dates FDA Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention