MAUDE Adverse Event Report: COVIDIEN ALTITUDE; APPARATUS, AUTOTRANSFUSION

Model Number	8888571370
Medical Device Problem Code	Air Leak (1008)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 12/22/17.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 or Problem Description
The customer states air in drainage.
Additional Manufacturer Narrative
An investigation into the reported condition was performed.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).Unfortunately without a sample we are unable to confirm the reported condition if a sample should be returned at a later date this complaint will be reopened and the investigation updated to reflect our findings.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process of lot 17d098fhx.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ALTITUDE
• Common Device Name: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): COVIDIEN; sragh industrial estate,rahan; tullamore
• MDR Report Key: 7143721
• Report Number: 9611018-2017-05015
• Device Sequence Number: 16462578
• Product Code: CAC
• UDI-Device Identifier: 20884521060972
• UDI-Public: 20884521060972
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/10/2022
• Device Model Number: 8888571370
• Device Catalogue Number: 8888571370
• Device Lot Number: 17D098FHX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/01/2017
• Supplement Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 12/22/2017
• Supplement Report FDA Received Date: 02/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1