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

Model Number 8888571299

Device Problem Suction Problem (2170)

Patient Problem No Patient Involvement (2645)

Event Date 04/21/2018

Event Type  malfunction  

Manufacturer Narrative

Submit date: 5/9/2018.The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If information is provided in the future, a supplemental report will be issued.

Event Description

Customer reports during a thoracoscopic surgical procedure when the aqua-seal cdu was being filled, the valve where the suction is connected was leaking which interfering with the function of the system.

• Brand Name: AQUA-SEAL
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): COVIDIEN; sragh industrial estate,rahan; tullamore
• Manufacturer (Section G): COVIDIEN; sragh industrial estate,rahan; tullamore
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7498955
• MDR Text Key: 107743605
• Report Number: 9611018-2018-00010
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 20884521060965
• UDI-Public: 20884521060965
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2022
• Device Model Number: 8888571299
• Device Catalogue Number: 8888571299
• Device Lot Number: 17B275FHX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/21/2018
• Date Device Manufactured: 02/24/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 74 YR