MAUDE Adverse Event Report: PERFUSION SYSTEMS AFFINITY PIXIE HFO AND PIXIE CVR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BBP241

Device Problem Obstruction of Flow (2423)

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

Event Date 08/31/2021

Event Type  malfunction  

Event Description

Medtronic received information that prior to use of an affinity pixie oxygenator with cardiotomy/venous reservoir during the priming procedure, the customer reported reduced venous return.When the customer was purging the arterial line to the venous line of the circuit a delay in venous return at the inlet of the oxygenator occurred.The device was replaced for the procedure.There was no patient impact associated with this event.Additional information: after the procedure the device was inspected and it was noted that uncoagulated blood was present in the reservoir.It was noted that when the pre-membrane line was removed, no clot formation of fibrin formation was observed at the entrance of the oxygenator.It was noted by the customer that the pixie oxygenator assembly checklist was routinely carried out in the conventional way with a non-medtronic support hemoconcentrator.The customer proceeded with purging protocol of the 7.5 kg patient circuit with solutions that they had available in the middle, which were sodium heparin 0.8ml and normal ringer 500ml.Already in the process a slight change was perceived in the three routine calibration tests per protocol, the light of the roller, free fall of the arterial line at 1 meter height, and the control of the post-membrane line with analog pressure showing a slow drop to the usual one; when purging the arterial line to the venous line of the circuit, the delay in the return to the venous inlet of the oxygenator draws attention, which goes unnoticed due to the increased flow on the roller without perceiving filtering or resistance faults in the circuit.At the urgency and presence of all accesses and permeable pathways ready for the patient, the customer proceed with blood priming per protocol with the cgr ab (red blood cell concentrate, type ab) and package using 150 cc of gradual drip to the reservoir without the presence of visual changes, this is when the concentrated red blood cells (rcc) is flushed and hemoconcentration of the priming at 25% of its process, where visual changes are noted in the venous return line at 50% but without the presence of leaks or resistance in the lines, a flow of up to 500 ml is maintained without fluttering of the lines but with medium to high resistance to touch in the ¼ pre-membrane silastic, immediately a marked reduction in venous return is observed up to 20% upon admission of the oxygenator, priming maneuvers are suspended and an immediate change of oxygenator was requested and main lines.After concluding with the acce ss routes to the patient by the anesthesia service (tot (gold tracheal tube), cvc (central venous catheter) , peripheral routes, arterial and vesical s.), the circuit is primed with crystalloid and then with blood in the oxygenator, to prevent the hemolysis of the roller due to the prolonged wait for cannulation and at the same time take advantage of the ultra-filtration (uf) for the elimination of co2 from the blood and oxygenate it in low volume for a short space and have the priming ready for the derivation.This is the hospital protocol in cardiopulmonary bypass neonatology.

Manufacturer Narrative

Conclusion: complaint not confirmed for the pixie cvr's reduced flow.No device returned for analysis.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 testing and inspections during manufacturing.Root cause is undetermined.There were no adverse patient effects 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.

• Brand Name: AFFINITY PIXIE HFO AND PIXIE CVR
• 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: 17072253
• MDR Text Key: 316786536
• Report Number: 2184009-2023-00426
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: BL
• 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
• Report Date: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: BBP241
• Device Catalogue Number: BBP241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2021
• 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