MAUDE Adverse Event Report: COVIDIEN ALTITUDE; APPARATUS, AUTOTRANSFUSION

Model Number 8888571370

Device Problem Suction Problem (2170)

Patient Problem Pneumothorax (2012)

Event Date 01/27/2018

Event Type  Injury  

Manufacturer Narrative

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 Description

The customer reported: 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 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; 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: 7481172
• MDR Text Key: 107161213
• Report Number: 9611018-2018-00009
• 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: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888571370
• Device Catalogue Number: 8888571370
• Device Lot Number: 171006FHX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention