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

Model Number	8888571299
Medical Device Problem Codes	Fluid/Blood Leak (1250); Suction Problem (2170)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	01/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process of 19b054fhx.The complaint report indicates that no sample is available in connection with this complaint report.Without a sample we are unable to perform a thorough follow up investigation to include functional and visual evaluation to confirm the reported issue or determine the root cause(s) of the reported condition or implement any corrective action(s).If a sample should be returned at a later date this complaint will be reopened and the investigation updated to reflect our findings.The manufacturing site reached out for further information and received a video of the unit.The investigation team tried to replicate what was observed in the video and could not get the same results.As a result of this we cannot confirm the issue experienced by the customer.The manufacturing site then engaged with the cardinal health r&d team to get a better understanding of the issue.The r&d team believes this may be a user issue based on some of the questions being asked, many of which are addressed in the instructions for use (ifu).The r&d team are conducting extensive cdu training and have extended an invite to the sales and marketing.This complaint will be used for qa tracking and trending purposes.
Event or Problem Description
The customer reported that the patient was connected to thoracic drainage which presents a permanent bubble that caused the water to rise above the initial level of the water seal and the water in the suction chamber evaporate.Also, the unidirectional valve is bidirectional and it does not work for positive suction.Received additional information on 29-jan-2020 stating that a patient was involved and developed pneumothorax.

• Brand Name: AQUA-SEAL CDU
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): COVIDIEN; sragh industrial estate, co, t; offaly ; EI
• MDR Report Key: 9729758
• Report Number: 9611018-2020-00406
• Device Sequence Number: 2482702
• Product Code: KDQ
• UDI-Device Identifier: 10884521060968
• UDI-Public: 10884521060968
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 8888571299
• Device Catalogue Number: 8888571299
• Device Lot Number: 19B054FHX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 02/19/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other