MAUDE Adverse Event Report: PERFUSION SYSTEMS AFFINITY HFO W/TRILLIUM 511T; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number 95215

Device Problem Insufficient Information (3190)

Patient Problems Abnormal Blood Gases (1034); Death (1802)

Event Date 12/04/2015

Event Type  Death  

Manufacturer Narrative

Medtronic has reached out to the health care facility in an attempt to obtain details of the event and clarification of the product performance allegation.Upon receipt of additional information, a supplemental report will be filed.(b)(4).

Event Description

Medtronic received information that a patient died in the intensive care unit (icu) two days after a bypass procedure where an affinity nt hollow fiber oxygenator was used.The health care professional (hcp) was concerned that co2 removal may not have occured properly during the procedure and may have been related to the patient's death.Medtronic is attempting to obtain further clarification.

Manufacturer Narrative

Conclusion: medtronic cannot confirm or deny a relationship between the oxygenator malfunction and the patient outcome for this event, as the product was not returned for analysis.A non-medtronic product involved in the procedure was returned, analyzed, and performed as expected during testing.This product was forwarded to the manufacturer.(b)(4).

Event Description

Medtronic received information that a patient died in the intensive care unit (icu) two days after a procedure where an affinity nt hollow fiber oxygenator was used.The health care professional (hcp) was concerned that co2 removal may not have occurred properly during the procedure and may have been related to the reported event.Additional information was obtained after a medtronic representative visited the hospital and learned that the customer's were specific to the non-medtronic gas blender that had been used in the case.There was no allegation that the medtronic oxygenator had caused or contributed to the clinical outcome.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: AFFINITY HFO W/TRILLIUM 511T
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5342753
• MDR Text Key: 34997503
• Report Number: 2184009-2016-00001
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K143073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 95215
• Device Catalogue Number: 95215
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/23/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 00062 YR