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

Model Number	8888571562
Medical Device Problem Code	Suction Failure (4039)
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 that the patient arrived post cardiac procedure.New drains (argylet sentinel sealt chest drain) were attached to patient and no training was given to the bedside nurse and they were unaware of the change of the drains.The theatre nurse gave a small handover of how to use the drain and to make sure it was draining.The drains arrived empty, and were meant to be bubbling as per theatre nurse instructions, but it was not.The drains did not drain anything in the first 30 minutes.The nurse in charge was informed and tried to adjust the suction, then 400mls dumped out of the drains and the patient did not become unstable during this episode.Hb (hemoglobin) was also stable.The drains once again stopped draining.The theatre staff was informed by the nurse in charge.The theatre staff bought a regular drain (pleuraseal) and attached the drain, straight away it drained 50mls, and continued to drain afterwards.Per additional information received, they removed the drain and replaced it with a pleuraseal one.
Additional Manufacturer Narrative
Samples were not received for the investigation.A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue and determine the root cause, therefore a corrective action is not applicable at this time.If a sample is received at a later date, this complaint will be reopened for further investigation.

• Brand Name: SENTINEL 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: 17871455
• Report Number: 9611018-2023-00622
• Device Sequence Number: 20207059
• Product Code: GCX
• UDI-Device Identifier: 10884521061026
• UDI-Public: 10884521061026
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2023

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: 8888571562
• Device Catalogue Number: 8888571562
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2023
• Supplement Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown