AFFINITY FUSION OXYGENATOR BB811

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-10 for AFFINITY FUSION OXYGENATOR BB811 manufactured by Medtronic, Inc..

MAUDE Entry Details

• Report Number: MW5087240
• MDR Report Key: 8687260
• Date Received: 2019-06-10
• Date of Report: 2019-05-29
• Date of Event: 2019-01-31
• Date Added to Maude: 2019-06-11
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT FAMILY MEMBER OR FRIEND
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: AFFINITY FUSION OXYGENATOR
• Generic Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Product Code: DTZ
• Date Received: 2019-06-10
• Catalog Number: BB811
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDTRONIC, INC.

Device Sequence Number: 2

• Brand Name: MEDTRONIC TUBING PACK
• Generic Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Product Code: DWF
• Date Received: 2019-06-10
• Catalog Number: HY8M45R9
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: MEDTRONIC, INC.

Device Sequence Number: 3

• Brand Name: AFFINITY CENTRIFUGAL BLOOD PUMP
• Generic Name: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Product Code: KFM
• Date Received: 2019-06-10
• Catalog Number: BBAP40
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: MEDTRONIC, INC.

Device Sequence Number: 4

• Brand Name: AFFINITY FUSION CARDIOTOMY
• Generic Name: RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS
• Product Code: DTN
• Date Received: 2019-06-10
• Catalog Number: BB841
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: MEDTRONIC, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2019-06-10