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

Model Number 8888571299

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported that on one occasion last week (w/c 20th february) the suction control chamber continued bubbling after the suction had been turned off.They replaced the cdu with a new aquaseal unit and the issue resolved.There was no problem for the patient because of this issue.Additional information received: there was bubbling in both the water seal chamber and the suction control chamber.The customer mentioned that when the suction was turned off, bubbling continued in the suction control chamber.

Manufacturer Narrative

The device history record (dhr) review could not be performed because the lot number was not available.The complaint report states that the sample has been discarded.Without a sample we are unable to perform a thorough follow up investigation to include functional and visual evaluation.If a sample should be returned later, this complaint will be reopened, and the investigation updated.No root cause can be determined as no sample was returned.No corrective or preventive actions will be taken at this time.A review of the line has been completed with no issue noted.During the manufacturing process, aquaseal vessels are all 100% leak tested and 100% functionally tested.This complaint will be used for tracking and trending purposes.

Manufacturer Narrative

H6 type of investigation, investigation findings, and investigation conclusions were updated.

• Brand Name: AQUA-SEAL CDU
• Type of Device: 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: 16589965
• MDR Text Key: 312199383
• Report Number: 9611018-2023-00580
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 10884521060968
• UDI-Public: 10884521060968
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2023

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?: Yes
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 03/22/2023
• Supplement Dates Manufacturer Received: 03/15/2023; 03/15/2023
• Supplement Dates FDA Received: 04/04/2023; 04/11/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1