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

Model Number 3600-100 - DRAIN DRY SINGLE W/AC

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 08/14/2023

Event Type  Injury  

Event Description

A member of the public has contacted the getinge brisbane office to report an incident in which he reportedly almost died after he was connected to an oasis chest drain for treatment of a pneumothorax.The circumstances of the alleged incident were not provided; however, this individual did explain that there was no malfunction of the drain and indicated that he did not think the clinicians knew how to use the drain properly.The individual requested training records for the hospital site, as well as inquired how the drain works, and requested to be sold a chest drain in order to prove he was mistreated whilst in the hospital.He was advised that getinge is unable to sell him a chest drain and to contact the hospital for further correspondence regarding his treatment.

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

N/a.

Manufacturer Narrative

A patient visited the getinge office in brisbane, australia and reported that he almost died while attached to an oasis (3600-100) drain in ipswich hospital.He stated that he was being treated for a pneumothorax, but believed the drain was not used correctly and wanted to acquire a drain and ifu to prove it.He also requested the hospital's training records.In a report to tga (attachment 4), the patient described that the patient tube of his drain was allowed to drape below the level of the drain, forming a dependent loop through which air passage was resisted.He believes that this was the cause of an adverse event.He stated that he believes the instructions for use should emphasize that the drain tube should always allow the free flow of the fluid into the measuring tubes inside the device.The patient iterated that he did not believe there was anything wrong with the device itself.The patient was told that any correspondence from him needs to go through the hospital and that getinge products could not be sold directly to him.He left an email address, which was used by getinge to request additional information about the incident, however the address the patient provided could not be reached.No details were provided about the setup of the device.No pictures or lot number of the device were provided.The patient claimed that he almost died due to the misuse of the drain, however no further details than that were provided.A dhr review could not be completed because no lot number was provided.The ifu provides adequate instructions for the setup and use of the device.If the ifu instructions had been followed by the user, it is unlikely this complaint could have occurred.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 no similar complaints.A recurring lot number report could not be completed because no lot number was provided.A review of crs/capas found none related to this complaint.A device nonconformance cannot be confirmed with the information provided by the complainant or discovered during this investigation.The complainant alleges that he nearly died because the hospital that treated him set up the drain incorrectly.In a tga report he describes that the patient tube was allowed to form a dependent loop which collected fluid in the tube for several days, resisting the passage of air.He also stated that he did not believe there was anything wrong with the drain.Attempts by getinge to acquire more information were not successful.The device was not returned for evaluation and no evidence was provided to support the claims.The described positioning of the patient tube is not something that should be allowed to persist for a long period of time, as it could prevent air from being drained.The ifu of the device instructs the user to regularly check patient tube connections, the water seal, suction regulator, and the suction bellows to ensure proper operation of the drain.If this instruction was followed, the patient line should have been noticed and cleared.While the complaint cannot be confirmed, the patient's description of the device setup suggests the root-cause of this complaint is user error.H3 other text: device not available for return.

• 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: 18282570
• MDR Text Key: 329939974
• Report Number: 3011175548-2023-00203
• Device Sequence Number: 1
• Product Code: KDQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/20/2024

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: 3600-100 - DRAIN DRY SINGLE W/AC
• Device Catalogue Number: 3600-100
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: 02/14/2024
• Supplement Dates FDA Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Outcome(s): Required Intervention
• Patient Sex: Male