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	05/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 6/27/2018; the incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Customer reports: on arrival to the dccm post-op cardiac bypass surgery, the altitude chest drain was placed on -20cmh20.The drain commenced bubbling constantly throughout inspiration and expiration on a ventilated patient.Suction was removed and the drain stopped bubbling.When the suction was reapplied, the drain resumed bubbling.The drainage tubing was then occluded, and the bubbling continued.When the suction was reduced to -10cmh20, the bubbling continued.The clinician changed the altitude drain to another altitude drain in stock, resumed -20cmh20 and the bubbling ceased.Swinging (oscillation) and drainage were unaffected.Per follow up information received, the customer further stated that there was a leakage in the water seal chamber.

• Brand Name: ALTITUDE
• Common Device Name: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): COVIDIEN; sragh industrial estate,rahan; tullamore
• MDR Report Key: 7643104
• Report Number: 9611018-2018-00012
• Device Sequence Number: 16593020
• Product Code: CAC
• UDI-Device Identifier: 20884521060972
• UDI-Public: 20884521060972
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 06/27/2018

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: 09/04/2022
• Device Model Number: 8888571370
• Device Catalogue Number: 8888571370
• Device Lot Number: 17I005FHX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2018
• Initial Report FDA Received Date: 06/27/2018
• Patient Sequence Number: 1