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

Model Number BBP211

Device Problems Gas Output Problem (1266); Increase in Pressure (1491); Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2022

Event Type  Injury  

Event Description

Medtronic received information that during use of a pixie oxygenator, it was reported that the clinician noted there was a difference between the 'dialed in' pump flow on the quantum heart and lung machine (hlm) controller and that on the arterial flow probe which was located between the oxygenator and patient.The clinician was concerned there was something wrong with blood flow delivery and increased the occlusion on the roller pump.They felt the tubing exiting the roller pump (between the pump and oxygenator) and described it as 'rock solid' to the touch indicating high pressures.Pre-oxygenator pressures are not measured.On increasing fio2 as per protocol for cyanotic children, the oxygenation did not increase as expected and the cerebral oximetry started to decrease from 80 to 40% (massimo nirs).Increasing the pump flow did not result in increased flow on the flow probe closest to the patient and manually palpated pressure remained great in the tubing.The patient was ventilated by the anesthetist, bypass was terminated and the oxygenator was changed out.Bypass recommenced, the two flows matched, pressure in the tubing was normal and oxygenation was within the expected range.There was no patient impact associated with this event.Prior to cardiopulmonary bypass (cpb), the majority of the pump prime was removed by retrograde autologous priming (rap) and on initiation of cpb 1000iu heparin was given.As per the facilities local policy, the child was cyanotic pre-cpb so cpb was commenced at a low fio2 to match the child (21%) so as expected venous saturations were low. the clinician questions a transmembrane pressure event or oxygenator blockage.A roller pump was used.No shunts were open other than sample manifold which would not account for the difference in pump flows.Act was measured using a actalyte 'grey tube'.The first act on cpb was 380s and 1000iu was given.Significant haematuria was seen and this cleared later in the bypass.

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.

Manufacturer Narrative

Device evaluation summary: visual inspection showed evidence of clotting/fibrin.Pressure integrity testing showed no internal or ex ternal leaks when run at 1 lpm with 23 psi, (1189 mmhg) of back pressure for 10 minutes.The device was sent to the blood lab for performance testing.Testing was conducted at a 1:1 ratio (2lpm blood gas flows) the results were as follows; 226 mm/hg delta pblood.The reason for return was undetermined.Conclusion: the complaint was not confirmed for the pixie oxygenator's pressure drop across the device.The issue was not verified via analysis of the returned device.Review of this devices¿ device history record found no abnormalities or non-conforming material reports (ncmrs) initiated during manufacturing that would cause or contribute to the reported event.This device passed all testing and inspections during manufacturing.It is suspected that the high pressure experienced by the customer may be related to a cold induced protein build up or cryoprecipitate which caused initial flow restriction in the device, or the patient or clinical condition at time of bypass or related to heparin potency.The root cause is undetermined.There were no patient/clinical safety issues reported.Trends for issues with this device are reviewed at quarterly quality meetings.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: 15648383
• MDR Text Key: 302166242
• Report Number: 2184009-2022-00278
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 20613994617310
• UDI-Public: 20613994617310
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: BBP211
• Device Catalogue Number: BBP211
• Device Lot Number: 223564729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2022
• Initial Date FDA Received: 10/21/2022
• Supplement Dates Manufacturer Received: 10/21/2022
• Supplement Dates FDA Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2021
• 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 Age: 4 YR
• Patient Sex: Male
• Patient Weight: 19 KG