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

Model Number BBP211

Device Problem Pumping Problem (3016)

Patient Problem Hypoxia (1918)

Event Date 09/24/2020

Event Type  malfunction  

Event Description

Medtronic received information that during use the customer noted the pixie oxygenator did not pump oxygen into the patient's blood.The oxygenator could not exchange gas while using (patient¿s blood was completely black), and patient¿s postoperative blood gas result was not good.It was a short procedure with a quick completion of the surgery to reactive patient¿s heart and lung.The oxygenator was used to complete the procedure.There was no adverse effect to the patient.The patient is now stable and discharged from the hospital.Additional information: patient was not administered any drug before procedure.Clotting was not observed in the oxygenator.Act measurement: by act ii (medtronic).

Manufacturer Narrative

Device evaluation summary: visual inspection shows the device was returned bloody.While cleaning the device there was a crack observed in the housing that ran all the way up through the potting of the fiber bundle.The crack was bonded with uv adhesive and the renalin solution ran through the crack in the potting to the top of the fiber bundle.With the device damaged, cracked through the potting performance testing can not be performed.Conclusion: complaint not confirmed for the pixie oxygenator's poor oxygenation.Analysis of the returned device showed evidence of a crack in the housing which prevented the device from proper cleaning and blood lab performance testing.It is possible this damage occurred during shipping/handling after leaving the customer's facility and prior to returning to medtronic.Review of this unit's device history record found no abnormalities or ncmrs initiated during manufacturing that would cause or contribute to the reported event.This unit passed all required testing during manufacturing.The ifu (m942408a001) states: ¿arterial po2 is controlled by varying the percent concentration of oxygen present in the ventilating gas.¿ and ¿gas transfer rates may change over time and adjustments of fio2 and gas flow rates may be needed to achieve desired gas transfer performance.¿ root cause is undetermined.No adverse patient effects were reported.Trends for issues with this product are reviewed at product quality meetings.This regulatory report is being submitted as part of a retrospective review and remediation per d00953163 as part of a capa action.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.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

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
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 17078859
• MDR Text Key: 316786155
• Report Number: 2184009-2023-00450
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: K183511
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BBP211
• Device Catalogue Number: BBP211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention
• Patient Sex: Male