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

Model Number 8888571406

Device Problem Decrease in Suction (1146)

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

Event Date 06/12/2023

Event Type  malfunction  

Event Description

The customer reported that the pacu rn paged to make them aware that the ¿suction port was loose and had to be taped down to hold suction¿.This was the first occurrence.The scrub tech did not notice any irregularities/defects upon filling the suction chamber prior to connecting the chest tubes.Upon removing the suction tubing from the port the next morning (assessing for air leak), the port was dislodging and attached to the suction tubing in which the doctor decided to leave the patient on water seal only instead of changing the complete system.Additional information received on 14jun2023 stated that the issue occurred while in use and caused diminished suction.

Manufacturer Narrative

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

Manufacturer Narrative

Based on the information available to us, we were unable to confirm the event.In the meantime, all information received will be used for further tracking and trending purposes.

• Brand Name: AQUA SEAL DUAL DRAIN 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: 17164583
• MDR Text Key: 317507123
• Report Number: 9611018-2023-00596
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 10884521061002
• UDI-Public: 10884521061002
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/28/2023

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 Operator: Health Professional
• Device Model Number: 8888571406
• Device Catalogue Number: 8888571406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/13/2023
• Initial Date FDA Received: 06/20/2023
• Supplement Dates Manufacturer Received: 06/13/2023
• Supplement Dates FDA Received: 07/28/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1