MAUDE Adverse Event Report: COVIDIEN ALTITUDE; APPARATUS, AUTOTRANSFUSION

Model Number	8888571370
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 05/12/17.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 reported significant leakage of pleural fluid at the blue fitting in the water seal.
Additional Manufacturer Narrative
One used sample was returned to the manufacturing facility.The returned unit is contaminated and as a result cannot be functionally tested using our test equipment.A visual inspection was complete on the returned unit to determine if there were any visual flaws that could lead to an issue with the unit.There was nothing noted during the visual inspection.Blue water was placed into the water seal chamber to determine if fluid is leaking from that chamber.The water level was visually checked 24 hours later and there was no evidence of blue water leaking from the water seal chamber.As the unit cannot be physically tested, also as there is no visual flaw in the system and there is no water leaking in the water seal chamber, the reported condition cannot be confirmed.During the manufacturing process all units are 100% leak tested and 100% functionally tested as part of the process.Also independent sampling is complete to confirm units are functioning correctly.A possible root cause for the complaint may be damage to the unit caused during transportation which could cause a leak in the unit.The associated data will be fed into the risk management quarterly report to assess the need for further corrective actions as this complaint is unconfirmed and considered an isolated event for this lot/product.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 6562958
• Report Number: 9611018-2017-05002
• Device Sequence Number: 616854
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/19/2017

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: 10/04/2021
• Device Model Number: 8888571370
• Device Catalogue Number: 8888571370
• Device Lot Number: 16J019FHX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/13/2017
• Supplement Date Received by Manufacturer: 04/13/2017; 04/13/2017
• Initial Report FDA Received Date: 05/12/2017
• Supplement Report FDA Received Date: 09/07/2017; 12/19/2017
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 58