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

Model Number BBAP40

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/16/2023

Event Type  malfunction  

Event Description

Medtronic received information that prior to use of a custom tubing pack, it was reported that the perfusionist was fluid priming the circuit.During priming the customer noticed a leak on the inlet side of the affinity cp pump head.The pump head was replaced.There was no patient involvement, so no adverse effect occurred.Medtronic received additional information that the same leak did not appear in multiple packs.The customer could not determine where exactly the leak was but mentioned the inlet of the centrifugal cone.There was no visible air in the system/tubing.There was no damage noted on the device.

Manufacturer Narrative

Device evaluation summary: upon receipt at medtronic¿s quality laboratory, visual inspection shows a crack at the base of the qb-inlet port.Pressure integrity testing was performed at 22 psig of air pressure with the device placed under water.During the test there was a leak observed from the base of the qb-inlet port.Reason for return was confirmed.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

Conclusion: complaint confirmed for a leak on the inlet side of the affinity cp pump head.The medtronic supplier quality team was consulted.It is also noted that a dhr review task was assigned when this complaint was previously entered in this complaint handling system as against the custom tubing pack.The dhr review was completed for the custom tubing pack lot, and the review did not identify any anomalies or deviations in the manufacturing process which would cause or contribute to the reported incident.Trends for issues with this product 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 CP 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: 16741414
• MDR Text Key: 313298294
• Report Number: 9612164-2023-01597
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 20613994647850
• UDI-Public: 20613994647850
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BBAP40
• Device Catalogue Number: BBAP40
• Device Lot Number: 225381230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2022
• 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