MAUDE Adverse Event Report: CARDINAL HEALTH AQUA-SEAL CDU; BOTTLE, COLLECTION, VACUUM

Model Number	8888571299
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.H3: device evaluation comment - the customer stated that the device will not be returned for evaluation because the device was contaminated.
Event or Problem Description
Customer reports: some of our customers have used the aqua seal cdu for the neonatal patients, and they could not identify any toddling or bubbling during the operation.The doctors are suspecting that this might be due to a device failure.The customers are concerned if the aqua seal cdu is designed to be used for neonatal patients as well and they are looking for an official confirmation in writing from the manufacturer.Therefore, you are kindly requested to clarify the above for our customers acknowledgement and later usage.Additional information was received that the patient is 9 months old.The volume of water in the seal chamber was 2cm and the suction was set to 20 cm.There were no kinks in the tubing and the product was replaced with an atrium brand.The patient is fine with no complication.There was bubbling and tideling which provided suction for a few minutes and it stopped working completely.
Additional Manufacturer Narrative
Based on the information available to us, we were not able to confirm the event.Updated section h10 - additional manufacturer narrative: the statement "based on the information available to us, we were able to confirm the event" has been updated to based on the information available to us, we were not able to confirm the event.
Additional Manufacturer Narrative
Based on the information available to us, we were able to confirm the event, and determined that: the device history record (dhr) review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.Since the physical sample was not provided the root cause and corrective actions could not be identified.If a sample is received in the future, the complaint will be reopened for investigation.This complaint will be used for tracking and trending purposes.All information received will be used for further tracking and trending purposes.

• Brand Name: AQUA-SEAL CDU
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; sragh industrial estate, co, t; offaly ; EI
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 19563773
• Report Number: 1423537-2024-00043
• Device Sequence Number: 14448306
• Product Code: KDQ
• UDI-Device Identifier: 10884521060968
• UDI-Public: 10884521060968
• Combination Product (Y/N): N
• Initial Reporter Country: KU
• 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): 07/15/2024

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
• Device Lot Number: 23E191FHX
• 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: 06/10/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 07/15/2024; 07/15/2024
• 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
• Patient Weight: 3 KG