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

Model Number 8888571299

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/23/2018

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

The customer reported the tightening ring detached from the unit.There was no harm to the patient.

Manufacturer Narrative

A physical sample was not returned for evaluation however a photo was provided.Without a sample we are unable to perform a thorough follow up investigation to include functional evaluation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.A visual inspection was completed on the photo and the defect has been confirmed.Without a sample we are unable to determine a definitive root cause.During the manufacturing of all aqua seal units they are all 100% leak tested and 100% functionally tested as part of the process.Also, independent sampling is complete to confirm units are functioning correctly.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.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: 8340369
• MDR Text Key: 136171627
• Report Number: 9611018-2019-00307
• 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: 03/27/2019

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: 17I172FHX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/06/2019
• Initial Date FDA Received: 02/14/2019
• Supplement Dates Manufacturer Received: 02/06/2019
• Supplement Dates FDA Received: 03/27/2019
• Patient Sequence Number: 1