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

Model Number 8888571299

Device Problem Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 1/23/2018.An investigation is currently under way; upon completion the results will be forwarded.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reports that the unit has a fault.While removing the syringe of water, the pressure valve breaks, which does not allow the proper functioning of the unit.

Manufacturer Narrative

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 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.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 probable root cause for the damage to the pressure valve is that the damage occurred during the transport.A review of the complaint tracking system for previous complaints against the lot number found no previous complaints against this lot number.The associated data will be fed into the risk management quarterly report.The device history record (dhr) review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process of lot 17b090fhx.If information is provided in the future, a supplemental report will be issued.

• Brand Name: AQUA-SEAL
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): COVIDIEN; sragh industrial estate,rahan; tullamore
• MDR Report Key: 7212998
• MDR Text Key: 98049432
• Report Number: 9611018-2018-00002
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 20884521060965
• UDI-Public: 20884521060965
• 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: 03/15/2018

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: Health Professional
• Device Expiration Date: 02/08/2022
• Device Model Number: 8888571299
• Device Catalogue Number: 8888571299
• Device Lot Number: 17B090FHX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/05/2018
• Initial Date FDA Received: 01/23/2018
• Supplement Dates Manufacturer Received: 01/05/2018
• Supplement Dates FDA Received: 03/15/2018
• Patient Sequence Number: 1