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

Model Number BBAP40

Device Problems Obstruction of Flow (2423); Noise, Audible (3273)

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

Event Date 01/09/2023

Event Type  malfunction  

Event Description

Medtronic received information that during use of a centrifugal pump, the customer reported a very loud squeal and a backflow alarms started.The customer then turned off cardioplegia, the pump was turned off, then on again and it had forward flow.The customer prepared the hand crank and began cardioplegia again, pump squealed and backward flow began for a second time.The customer separated the pump from affinity cp adapter plate and the adapter plate was removed to place on the hand crank.The customer tried the pump again and they had forward flow.There were no adverse patient effects because of this issue.The customer stated that the patient's core temperature was 36.4 degrees celsius and twice there was no flow to patient (10-20 seconds each).It was approximately 1 minute from the first alarm to the last alarm.

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 50 decibels, as compared to the specification of 68 decibels.There was 8 lpm of flow with no noise or squealing noted.Reason for return was not 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

Medtronic received additional information that the arterial rpm and flow prior to cardioplegia on and ¿squeal¿ of pump was 4.6 lpm and unknown rpm.There was no retro-guard or one-way valve in the arterial line.The act was 560.There were no visible clots.When the flows re-established, the same adapter plate, motor head and disposable centrifugal pump were used.There was no wobble noticed prior to or during the incident.The customer used a non-medtronic cardioplegia system, running at approximately 300ml/min.The pump stopped spinning twice.The controller did not lose power.Regarding the length of time the pump had been in use, it was primed at approximately 07:00 and the incident occurred at 10:19.The pump was not damaged in any way.The pump was never transferred to the hand crank.The pump was not transferred to a new instrument.The pump and adapter were used in a non-medtronic drive motor.The customer does not know if the allegation is that the adapter caused or contributed to the flow issue as they no longer have the adapter and they have not had this issue again.It is possible that the allegation is at that the adapter caused or contributed to the noise issue.It was noted that the noise was very loud.It was not just a squeak but a very loud grinding noise as well.It did not seem to be coming from the motor itself but the customer cannot be sure.It was very fast and then there were alarms with the retrograde flow.This occurred twice, the customer mentioned that perhaps it was the centrifugal pump itself.The customer did not use a replacement pump to complete the case after these issues occurred.Correction h1: as the additional information received confirmed that the hand crank was not used, and there was no intervention required, this event no longer meets the criteria of a serious injury stipulated in 21 cfr 803.Updated to reportable malfunction.Correction h6: imf (annex f) updated to f26.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 not confirmed for the centrifugal pump loud squeal and backflow.Medtronic medical education was consulted.It is most likely that the adapter decoupled from the motor or the pump decoupled from the adapter.The possible cause per dfmeca revision that would be consistent with the complaint information (flow re-established using the same adapter plate, motor, and centrifugal pump) and the returned product analysis results is, user does not seat pump properly onto adapter.There were no patient adverse effects, will continue to monitor for future events.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

Correction b1: updated to product problem.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: 16321648
• MDR Text Key: 309020585
• Report Number: 2184009-2023-00072
• 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,Followup,Followup
• Report Date: 07/10/2023

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: 05/17/2024
• Device Model Number: BBAP40
• Device Catalogue Number: BBAP40
• Device Lot Number: 224339828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA Received: 02/08/2023
• Supplement Dates Manufacturer Received: 03/30/2023; 03/30/2023; 07/07/2023
• Supplement Dates FDA Received: 04/25/2023; 07/05/2023; 07/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2022
• 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): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 98 KG