MAUDE Adverse Event Report: COVIDIEN ALTITUDE; APPARATUS, AUTOTRANSFUSION

Model Number	8888571370
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 8/4/2017.An investigation is currently under way; upon completion the results will be forwarded.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reports leak at the level of "satchel".There are some abnormal bubbles.While the patient had a pulmonary leak problem.The "satchel" doesn't work, therefore no suction for the patient.
Additional 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 manufacture of altitude dry cdu units, each unit is leak tested after the unit is welded and glued to detect for leaks in the unit.Also prior to packing each unit is functionally tested to ensure that it functions correctly which includes a leak test in the unit.The most probable root cause is that the packaging was damaged post transport from the manufacturing site / during transport.The associated data will be fed into the risk management quarterly report.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: 6768361
• Report Number: 9611018-2017-05008
• Device Sequence Number: 1491675
• Product Code: CAC
• UDI-Device Identifier: 20884521060972
• UDI-Public: 20884521060972
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2018

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: 06/14/2021
• Device Model Number: 8888571370
• Device Catalogue Number: 8888571370
• Device Lot Number: 16F101FHX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/06/2017
• Supplement Date Received by Manufacturer: 07/06/2017
• Initial Report FDA Received Date: 08/04/2017
• Supplement Report FDA Received Date: 01/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1