MAUDE Adverse Event Report: PERFUSION SYSTEMS AFFINITY AP40 CENTRIFUGAL PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLE

Model Number AP40C

Device Problems Mechanical Problem (1384); Obstruction of Flow (2423)

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

Event Date 06/15/2021

Event Type  malfunction  

Event Description

Medtronic received information that during use of an ap40 affinity pump, tx-50 bio-probe, external drive motor and bio-console, the user was reporting that the flow quantity was not available at the start of the pump.It was found that when a de-vascularization was inserted into the patient and the pump speed was increased, there was no flow.It was unknown whether the wings of ap40 were rotating since blood was stuck.It worked normally when it was raised to max on the recirculation side where there was no resistance.Use of devices was continued and the procedure was completed.There were no adverse patient effects associated with this event.There was no problem noted at priming of the product.The customer stated there were no clamped lines.The ap40 was not used with an ap40ast.The customer stated that there were no clamped lines when the issue occurred.

Manufacturer Narrative

Device evaluation summary: upon receipt at medtronic¿s quality laboratory, visual inspection showed no outward signs of any damage.The device was tested per specification.The device was run on a bio console from 0-4000 rpm¿s, using fluid.The noise level recorded during the analysis was less than 60 decibels, as compared to the specification of 68 decibels.There was flow observed from 0 to 7 lpm.Reason for return was not confirmed.Conclusion: the reason for return was not confirmed for no flow.No patient / clinical safety issues reported.Trends for issues with this product are reviewed at quarterly 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.

• Brand Name: AFFINITY AP40 CENTRIFUGAL PUMP
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLE
• 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: 17247849
• MDR Text Key: 318578116
• Report Number: 2184009-2023-00769
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K191077
• 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: 07/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AP40C
• Device Catalogue Number: AP40C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2021
• Initial Date FDA Received: 07/03/2023
• 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