MAUDE Adverse Event Report: COVIDIEN AQUA-SEAL CDU; APPARATUS, AUTOTRANSFUSION

Model Number 8888571299

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/30/2019

Event Type  malfunction  

Manufacturer Narrative

Submit date: 10-apr-2019.An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported the thoracic drainage system was broken.Follow up received on (b)(6) 2019 stated at the time of preparing the drainage system to connect with the chest tube the water chamber was filled and began to flow out of the sewer system.The leak came from the water seal chamber.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Although the complaint report states that a sample would be returned, a sample has not been received.Without a physical sample we are unable to perform a thorough follow up investigation to include functional evaluation.However a photograph was provided for review.After reviewing the photograph, the manufacturing site believes that the crack occurred during the transport.During the manufacturing of all aqua seal units are 100% leak tested and 100% functionally tested as part of the process.Also independent sampling is completed to confirm units are functioning correctly.A probable root cause for the damage to the pressure valve is that the damage occurred during the transport.The manufacturing site has informed the production area of the reported issue.At this time, there is not enough information and no actions will be initiated at this time.If the physical sample is received at a later date, this complaint will be re-opened and the investigation continued.This complaint will be used for qa tracking and trending purposes.

• Brand Name: AQUA-SEAL CDU
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): COVIDIEN; sragh industrial estate, co, t; offaly ; EI
• MDR Report Key: 8500229
• MDR Text Key: 141485736
• Report Number: 9611018-2019-00308
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/06/2019

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: No Information
• Device Model Number: 8888571299
• Device Catalogue Number: 8888571299
• Device Lot Number: 17EO78FHX
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/06/2019
• Initial Date FDA Received: 04/10/2019
• Supplement Dates Manufacturer Received: 04/06/2019
• Supplement Dates FDA Received: 08/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1