MAUDE Adverse Event Report: COVIDIEN LP ALTITUDE; APPARATUS,AUTOTRANSFUSION

Lot Number 171006FHX

Device Problems Device Operates Differently Than Expected (2913); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems Pneumothorax (2012); Low Oxygen Saturation (2477)

Event Date 01/27/2018

Event Type  malfunction  

Event Description

The patient had a bilateral lung transplant in the early hours of the day a few months ago.The patient started to desaturate in the evening.An x-ray was obtained and there was a large pneumo on the left.The medical doctor's had us remove her chest dressing and place a new one to try and relieve pressure.During all this we found the chest tube to be open in the back.The covidien substitute chest tube has a large port in the back for filling that will often pop open which causes the chest drain to lose all the suction in the system.The medical doctor's are not sure if this was the main cause of the pneumo or if it just made things worse.The atrium chest drain system is our normal system but was on back order so the hospital used this.

• Brand Name: ALTITUDE
• Type of Device: APPARATUS,AUTOTRANSFUSION
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 7365423
• MDR Text Key: 103311602
• Report Number: 7365423
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/20/2018,03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/04/2022
• Device Lot Number: 171006FHX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/20/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 19 YR