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

Model Number BBAP40

Device Problems Mechanical Problem (1384); Material Separation (1562); Noise, Audible (3273)

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

Event Date 11/09/2021

Event Type  malfunction  

Manufacturer Narrative

Product analysis #271372739:1/18/22 - device will be sent to japan visual analysis: visual inspection shows the impeller is loose inside the housing.Performance analysis: the device was tested per specification m939509a001.The device was run on a bio console from 0-4000 rpm¿s, us ing fluid, at lower rpm's there was a wobble observed, (see video).The device was cut apart and the impeller shaft to shaft dimension was measured using an optical comparator to be 29.8 mm, the specification zj15858 has the dimension to be 31.2 +/- 0.2 mm, (see photo).There was some damage observed to the top and bottom bushing(s), (see photos).Conclusion: reason for return was confirmed.Unit will be held in brooklyn park.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.

Event Description

Medtronic received information that prior to use of an ap40 centrifugal pump, the customer reported that the cone decoupling during priming (prior to the bypass case).The white plastic piece was moving around a lot in the cone and causing a noise.The centrifugal pump was replaced for the procedure.There was no patient involvement so no adverse effect occurred.Additional information: there was no damage noted to the cone itself and the packaging was not damaged either.The ap40 was part of the following custom tubing pack.Model number: bb4z62r19 lot number: 222738581.

• 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: 17180374
• MDR Text Key: 317772596
• Report Number: 2184009-2023-00593
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132712
• 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
• Report Date: 06/22/2023

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: BBAP40
• Device Catalogue Number: BBAP40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 06/22/2023
• 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