MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION DRAINS OASIS SINGLE; BOTTLE, COLLECTION, VACUUM

Model Number 3600-100

Device Problem Patient Device Interaction Problem (4001)

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

Event Date 09/01/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Call received from the nicu about a 34 gestational week, premature birth ( 3 days old ) infant with an 8fr pigtail drain connected to an atrium oasis drain.She says that they have had issues the drain for several hours, needing to adjust the drain to -40 suction to actually resolve the pneumonia.They do not feel comfortable with the suction this high and they are curious if the small pigtail catheter has caused the need for the higher suction.All the connections are tight, and there are bubbles in the air leak chamber.The drains are reportedly patent.They have questions about trials utilizing the oasis in the nicu patients, and if there are issues with pigtail catheter and the oasis drain.The nicu director also asked about an in-service training.

Event Description

N/a.

Manufacturer Narrative

Investigation: this complaint reported that an oasis drain (p/n 3600-100, l/n unknown) was connected to a nicu patient using an 8 fr pigtail catheter to treat a "pneumonia" (it is assumed this was a typo and intended to say pneumothorax).The customer expressed concern that they had to adjust the suction regulator to -40 cmh2o in order to resolve the pneumothorax.They stated that they were uncomfortable using such a high suction and wanted to know if the pigtail catheter could be responsible.The customer reported that all the connections were tight, there were bubbles in the air leak chamber, and the drain was patent.Additionally, they asked about the possibility for in-service training.No pictures or lot number were provided and the device has not been returned for evaluation.The customer stated that there was no harm to the patient due to the delay in treatment.They used the adult drain on a pediatric patient because they did not have the drain they typically would use.Water was filled to the 2cm mark and the bellows expanded to its mark under suction.The make and model of the pigtail catheter is not known, however it is known that the size was 8 fr.It is unknown which drain this customer typically uses for pediatric patients, but pediatric drains have lower internal volumes than adult drains.The oasis pediatric drain (3612-100) has a fill volume of 200 ml while the adult drain (3600-100) has a fill volume of 2,100 ml.Because pediatric patients have smaller lung capacities, in order to overcome the additional "dead air space" of an adult drain, higher than usual suction may need to be applied and it can take longer for air to move through the space.Additionally, the suction regulator of the 3600-100 drain is designed to go to -40 cmh2o.The 8 fr pigtail catheter is smaller than the intended size for the 3600-100 drain (the pre-attached connector attaches to thoracic catheters from 24-40 fr).An 8 fr catheter is too small to be attached normally and it is unknown if an adaptor or other method was used to make the connection.A medical assessment was completed which concluded that the cause of this complaint could be related to multiple factors such as improper setup, lack of an appropriate connector, use of the pigtail catheter, and in particular the use of an adult drain on a pediatric patient.Although the adult drain does not increase risk of harm to the patient when used properly, it may require higher suction and take more time for treatment.The lot number of the device was not provided so a dhr review could not be completed.The complaint details do not indicate that there was an issue with manufacturing, materials, equipment, or design.The ifu provides adequate instructions for use of the device, including the volumes and compatible catheter sizes for both adult and pediatric drains.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 one similar complaint of an adult oasis drain used on a pediatric patient.The root-cause of that complaint was user error.A recurring lot number report could not be completed because the lot number was not provided.A review of crs/capas found none related to this complaint.Neither the complaint nor a device nonconformance can be confirmed.The information provided by the customer indicates they used an adult drain on a pediatric patient with an 8 fr catheter, which would not fit the connector of the 3600-100 drain.The patient's condition was resolved and there was no indication of a device failure.The customer was just concerned that they needed to set the suction regulator to -40 cmh2o to resolve the pneumothorax.The root-cause of this complaint is user error.

• Brand Name: DRAINS OASIS SINGLE
• 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: 17761610
• MDR Text Key: 323585010
• Report Number: 3011175548-2023-00179
• Device Sequence Number: 1
• Product Code: KDQ
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• 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?: No
• Date Manufacturer Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 3 DA
• Patient Sex: Male
• Patient Weight: 2 KG