MAUDE Adverse Event Report: CARDINAL HEALTH AQUA-SEAL CDU; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number	8888571299
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported the doctor asked for advice with regards to stepping down the suction from the suction control chamber of the aqua-seal chest drain unit - how to reduce the fluid in the suction control chamber.There is no information in the ifu about this.Within conversation, it was mentioned that blue dye was noticed in the suction control chamber.This was noticed as the cdu was being disconnected during clamping off.It is unknown if the wall suction was left on.Blue dye from the water seal chamber was noticed in the suction control chamber after use.
Additional Manufacturer Narrative
The device history record (dhr) review could not be reviewed because a lot number was not available.No sample was available for evaluation.If a sample is returned later, this complaint will be reopened and the investigation updated.We are unable to confirm the reported condition.No root cause or corrective action will be taken at this time.A review of the line has been completed with no issues detected.During the manufacturing process on aqua seal vessels, they are all 100% leak tested and 100% functionally tested as part of the process.This complaint will be used for tracking and trending purposes.
Additional Manufacturer Narrative
The instructions for use (ifu) contains information in relation to functions of the suction control chamber.There is information regarding filling the suction control chamber, how to determine vacuum, use with suction sources, suction levels, as well as further information on usage of the aqua seal vessel.

• Brand Name: AQUA-SEAL CDU
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; sragh industrial estate, co, t; offaly ; EI
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 17509469
• Report Number: 9611018-2023-00612
• Device Sequence Number: 6216967
• Product Code: GCX
• UDI-Device Identifier: 10884521060968
• UDI-Public: 10884521060968
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/20/2023

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 Model Number: 8888571299
• Device Catalogue Number: 8888571299
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2023
• Supplement Date Received by Manufacturer: 08/04/2023; 08/04/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 09/15/2023; 10/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown