MAUDE Adverse Event Report: PERFUSION SYSTEMS AFFINITY CP CENTRIFUGAL BLOOD PUMP; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number AP40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemolysis (1886)

Event Date 01/07/2021

Event Type  Injury  

Event Description

Medtronic received information via literature that a patient was hospitalized for severe h1n1 influenza.Because of a rapid deterioration with respiratory failure, she was tracheostomized on the fifth day after admission.Respiratory failure worsened under mechanical ventilation and ecmo support was initiated 7 days later.The pump performance failed after 48 hours and it was replaced by a custom circuit including a medtronic biomedicus pump and ¼" tubing.It was noted hemolysis occurred 5 days later (with worsening anemia, increasing lactate dehydrogenase and decreasing haptoglobin levels, and hemoglobinuria).The device was replaced for the remainder of the ecmo support.Based on the available information, the hemolysis may have been attributed to the medtronic product.

Manufacturer Narrative

Outcomes attributed to adverse event: other, adverse event with no outcome reported.Citation: martucci.Inferior vena cava surgical cannulation for infants needing veno-venous extracorporeal membrane oxygenation.Perfusion.2022, vol.37(2).128¿133.Doi: 2022, vol.37(2).128¿133.Doi: 10.1177/0267659120987089.The e-publish date was used for event date.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.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

Continued from h6, fdc d1103: review of the case determined that the pump was used for 67 days during an ecmo case.This pump was not labeled for more the 6 hours of use, so this would be considered off-label use for this pump.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 CP CENTRIFUGAL BLOOD PUMP
• Type of Device: TUBING, PUMP, 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: 14756066
• MDR Text Key: 294407493
• Report Number: 2184009-2022-00142
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K191077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AP40
• Device Catalogue Number: AP40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2022
• 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): Other
• Patient Age: 8 MO
• Patient Sex: Female
• Patient Weight: 8 KG