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

Model Number 16400

Device Problems Off-Label Use (1494); Inadequate Instructions for Non-Healthcare Professional (2956)

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

Event Date 12/06/2021

Event Type  malfunction  

Manufacturer Narrative

This mdr is being submitted as part of a retrospective review.During activities being performed for capa 682612 (associated with express mini 500 continued use and use of devices outside of the healthcare setting), atrium medical corp.Became aware of calls received by the getinge emergency support program (esp) team that were not logged as complaints.A retrospective review of the calls logs has resulted in the identification of this complaint/mdr.Upon completion of the investigation into this event a follow up report will be submitted.

Event Description

Home patient and spouse called regarding the express mini 500 attached to her husband's chest drain catheter.She was concerned because the check mark no longer was seen as oscillating or intermittent.It was now always seen in the window.I quoted her the ifu stating "when the check mark appears, it means vacuum (negative pressure) is present inside the chest drain.When no vacuum is present inside the chest drain, such as when the patient has an air leak on gravity drainage, the check mark will not appear.The check mark may appear intermittently with respiration." she was happy that this noted the healing process and thanked me for the time i spent talking with her and her husband.

Manufacturer Narrative

Investigation summary: the information provided stated that a home patient and spouse called regarding the express mini 500 attached to her husband's chest drain catheter.She was concerned because the check mark no longer was seen as oscillating or intermittent.It was now always seen in the window.I quoted her the ifu stating "when the check mark appears, it means vacuum (negative pressure) is present inside the chest drain.When no vacuum is present inside the chest drain, such as when the patient has an air leak on gravity drainage, the check mark will not appear.The check mark may appear intermittently with respiration." she was happy that this noted the healing process and thanked me for the time i spent talking with her and her husband.The lot number for this device was not provided so a dhr review cannot be completed and ncrs and incoming inspection records involving these devices cannot be reviewed.The ifu provides adequate instructions for the use of the device.It warns the user not to use this drain if fluid drainage is expected to exceed 500ml per day and not to attempt to reuse the device.It also cautions the user to replace the device once it's collection volume reaches max capacity.It states that the drain should only be used by a healthcare provider and that the drain should not be emptied.A field notification was sent to atrium customers on march 01, 2023 with additional instructions that the drain is restricted for use in a healthcare facility and that the drain should not be emptied.At this time, an interim label was also applied to the product being distributed.A complaint history review was completed which found 37 similar complaints involving outpatient use associated with the luer port becoming clogged.A recurring lot number report could not be completed without the lot number.A review of crs/capas found 5 related crs and 2 related capas in the two years prior to this event.No evidence was identified to suggest this complaint is related to manufacturing, materials, or design of the device.The hazardous situation/harms is addressed in the harm hazards analysis document which assigns the reported defect a severity level of 1.This was determined to be appropriate based on the harm that was reported in the complaint.Based on the information provided in the complaint and the results of the investigation, the complaint can be confirmed, however device nonconformances cannot.The information provided indicates that the device was used outside the intended environment and in a way that was not intended.Emptying and continuing to use the drain is not recommended.Use of the drain by someone who is not a medical professional is not recommended.People who are not medical professionals are not expected to know how to operate or interpret the drain.The field safety notification and the interim label make it clear that the device is not intended for outpatient use.The root-cause of this complaint is user error, due to outpatient use of the drain.H3 other text : device not available for return.

Event Description

N/a.

Manufacturer Narrative

Investigation summary: the information provided stated that a home patient and spouse called regarding the express mini 500 attached to her husband's chest drain catheter.She was concerned because the check mark no longer was seen as oscillating or intermittent.It was now always seen in the window.I quoted her the ifu stating "when the check mark appears, it means vacuum (negative pressure) is present inside the chest drain.When no vacuum is present inside the chest drain, such as when the patient has an air leak on gravity drainage, the check mark will not appear.The check mark may appear intermittently with respiration." she was happy that this noted the healing process and thanked me for the time i spent talking with her and her husband.The lot number for this device was not provided so a dhr review cannot be completed and ncrs and incoming inspection records involving these devices cannot be reviewed.The ifu provides adequate instructions for the use of the device.It warns the user not to use this drain if fluid drainage is expected to exceed 500ml per day and not to attempt to reuse the device.It also cautions the user to replace the device once it's collection volume reaches max capacity.It states that the drain should only be used by a healthcare provider and that the drain should not be emptied.A field notification was sent to atrium customers on march 01, 2023 with additional instructions that the drain is restricted for use in a healthcare facility and that the drain should not be emptied.At this time, an interim label was also applied to the product being distributed.The complaint investigation identified an additional 60 express mini¿s complaints related to outpatient use.A recurring lot number report could not be completed without the lot number.A review of crs/capas found 5 related crs and 2 related capas in the two years prior to this event.No evidence was identified to suggest this complaint is related to manufacturing, materials, or design of the device.The hazardous situation/harms is addressed in the harm hazards analysis document which assigns the reported defect a severity level of 1.This was determined to be appropriate based on the harm that was reported in the complaint.Based on the information provided in the complaint and the results of the investigation, the complaint can be confirmed, however device nonconformances cannot.The information provided indicates that the device was used outside the intended environment and in a way that was not intended.Emptying and continuing to use the drain is not recommended.Use of the drain by someone who is not a medical professional is not recommended.People who are not medical professionals are not expected to know how to operate or interpret the drain.The field safety notification and the interim label make it clear that the device is not intended for outpatient use.The root-cause of this complaint is user error, due to outpatient use of the drain.

• 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: 18681804
• MDR Text Key: 336085168
• Report Number: 3011175548-2024-00043
• Device Sequence Number: 1
• Product Code: KDQ
• 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: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2024

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: 12/06/2021
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: 03/11/2024; 04/17/2024
• Supplement Dates FDA Received: 03/12/2024; 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male