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

Model Number AP40

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

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

Event Date 11/22/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone number requested, but unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use of this ap40 centrifugal pump during an extra-corporeal membrane oxygenation (emco) operation, it was noted that the patient's blood flow rate was slow, and it was found that the centrifugal pump head axis of the centrifugal pump was offset.The pump had been in use for 25 minutes when the issue occurred.After replacing the centrifugal pump head with a new centrifugal pump, the patient's blood flow could reach the normal flow rate.There were no adverse patient effects as a result of this issue.Additional information: the perfusion records provided for the case were 85/47 mmhg, rotating speed 2080.The priming solution was composed of normal saline and heparin.Norepinephrine and dobutamine were used during the case.

Manufacturer Narrative

Device evaluation summary: the device was returned bloody with evidence of a clot around the upper pivot.Visual inspection shows the impeller is loose inside the housing.The device was tested per specification.The device was run on a bio console from 0-4000 rpm¿s, using fluid, a noise level greater than 80 db was recorded, specification is less than 68 db.The device was cut apart and the pin on the top of the impeller is melted into the impeller, there appears to be some damage to the mating bushing.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: the complaint was confirmed for the offset centrifugal pump head axis of the centrifugal pump.The device was returned bloody with evidence of a clot around the upper pivot.Visual inspection showed the impeller was loose inside the housing.For performance analysis, the device was tested per specification.The device was run on a bio-console from 0-4000 rpm using fluid; a noise level greater than 80 db was recorded.The specification is less than 68 db.The device was cut apart, and the pin on the top of the impeller was melted into the impeller.There appeared to be some damage to the mating bushing.If the pump is run with insufficient fluid, for example in the presence of thrombus formation, this will cause degradation of the bearing, which would result in the damage and noise found by the product analysis.Saline or blood is required during use to cool the ceramic pump bearing.Per the indications for use, "formation of thrombus in the circuit may increase the risk of damage to the perfusion system equipment.A strict anticoagulation protocol should be followed, and anticoagulation should be routinely monitored during all procedures.The prescribing physician must weigh the benefits of extracorporeal support against the risk of systemic anticoagulation.Adequate heparinization should be maintained per institution cardiopulmonary bypass protocol." trends for issues with this device are monitored.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: 13008555
• MDR Text Key: 284521752
• Report Number: 2184009-2021-00119
• Device Sequence Number: 1
• Product Code: DWE
• UDI-Device Identifier: 00643169855205
• UDI-Public: 00643169855205
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2023
• Device Model Number: AP40
• Device Catalogue Number: AP40
• Device Lot Number: 221911960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2021
• 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
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 156 KG