MAUDE Adverse Event Report: MEDTRONIC PERFUSION SYSTEMS AFFINITY; FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE

Model Number AFFINITY

Device Problems Restricted Flow rate (1248); Device Inoperable (1663)

Patient Problem Low Oxygen Saturation (2477)

Event Date 12/14/2017

Event Type  malfunction  

Event Description

Commenced bypass procedure.Blood color was dark indicating blood was not being oxygenated.Surgeon and anesthesia notified immediately.Blood sample was pulled from circuit before coming off of bypass.Came off bypass so patient could breath on his own.Arterial po2 on blood gas from the circuit was 31.Patient's saturation became greater upon breathing on his own.Confirmed oxygen source unobstructed.Confirmed oxygen source was blowing.Moved gas lines to another room to confirm oxygen source.Commenced bypass a second time for 60 seconds.Confirmed oxygenator not working changed out oxygenator.Commenced bypass a third time, and oxygenation was appropriate.

• Brand Name: AFFINITY
• Type of Device: FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE
• Manufacturer (Section D): MEDTRONIC PERFUSION SYSTEMS; 7611 northland dr.; minneapolis MN 55428
• MDR Report Key: 7198983
• MDR Text Key: 97544449
• Report Number: 7198983
• Device Sequence Number: 1
• Product Code: DTM
• 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: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/28/2019
• Device Model Number: AFFINITY
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/10/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR