MAUDE Adverse Event Report: COVIDIEN ALTITUDE; APPARATUS, AUTOTRANSFUSION

Model Number 8888571370

Device Problem Suction Problem (2170)

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

Event Date 06/21/2017

Event Type  malfunction  

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 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.

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
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): COVIDIEN; sragh industrial estate,rahan; tullamore
• Manufacturer (Section G): COVIDIEN; sragh industrial estate,rahan; tullamore
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6768361
• MDR Text Key: 81907805
• Report Number: 9611018-2017-05008
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 20884521060972
• UDI-Public: 20884521060972
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2017
• Date Device Manufactured: 06/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1