|
Model Number 16400 |
Device Problems
Complete Blockage (1094); Off-Label Use (1494)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/31/2023 |
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
|
Son of home patient called for help with the express mini.He has been emptying it via the leur port and now can't pull back any fluid from the port.I advised that the recommendation is to actually replace the drain with another when it is full, and that the leur is not meant to be used as a way to empty the drain.There is 300ccs of fluid in the drain, and he says that it likely would not fill in the next few days.I suggested that he contact her doctors office about further instructions, and about obtaining another drain.
|
|
Manufacturer Narrative
|
Investigation summary: the information provided stated that a son of home patient called for help with the express mini.He has been emptying it via the leur port and now can't pull back any fluid from the port.I advised that the recommendation is to actually replace the drain with another when it is full, and that the leur is not meant to be used as a way to empty the drain.There is 300ccs of fluid in the drain, and he says that it likely would not fill in the next few days.I suggested that he contact her doctors office about further instructions, and about obtaining another drain.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.
|
|
Event Description
|
N/a.
|
|
Manufacturer Narrative
|
Additional information: section h6 investigation summary: the information provided stated that a son of home patient called for help with the express mini.He has been emptying it via the leur port and now can't pull back any fluid from the port.I advised that the recommendation is to actually replace the drain with another when it is full, and that the leur is not meant to be used as a way to empty the drain.There is 300ccs of fluid in the drain, and he says that it likely would not fill in the next few days.I suggested that he contact her doctors office about further instructions, and about obtaining another drain.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.
|
|
Search Alerts/Recalls
|
|
|