MAUDE Adverse Event Report: PERFUSION SYSTEMS AFFINITY PIXIE PEDIATRIC HOLLOW FIBER OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BBP211

Device Problem Gas Output Problem (1266)

Patient Problem Low Oxygen Saturation (2477)

Event Date 07/28/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use of a pixie oxygenator, the customer reported that there were abnormal po2 results.The patient had to be ventilated while they came off pump. .

Event Description

The po2 of the tests, gave results below the critical index of the reference, out of the normal po2 (t) 29 mmhg, under the critical index of 45 mmhg.The customer stated the expected measurement is 83 to 108 mmhg and even with 100% fio2 the measurement only reached 33 mmhg, it always remained below the critical index of 45 mmhg.The physicians of the perfusion team requested that the anesthesia team enter to ventilate as support while they left the extracorporeal circulation pump.They insisted that the time of the procedure was short.The team of physicians have asked that the oxygenator be analyzed, because they checked everything else and it was as expected, the customer had a new blender, vaporizer and it was also as expected.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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 PIXIE PEDIATRIC HOLLOW FIBER OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 12376312
• MDR Text Key: 268436033
• Report Number: 2184009-2021-00074
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K183511
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BBP211
• Device Catalogue Number: BBP211
• Device Lot Number: 2110261411
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 16