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

Model Number BBAP40

Device Problems Crack (1135); Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/19/2022

Event Type  malfunction  

Manufacturer Narrative

Product analysis: visual inspection showed 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.The 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.

Event Description

Medtronic received information that during use of a custom tubing pack, it was reported that after priming and the arterial line was connected, a small volume of fluid was given before going on bypass.The customer observed that before going on bypass, a small amount of fluid was under the centrifugal pump head.The customer inspected the centrifugal pump head and observed what appeared to be a leak from a crack at the tip of the head.The device was replaced by the customer changing the pump head out and the rest of the circuit was used without any further incident to complete the procedure.There was no additional patient impact associated with this event.Medtronic received additional information that the same leak did not appear in multiple custom tubing packs.There were no visible air in system/tubing.The patient lost 10ml of blood at most as a result of this leak.No transfusion was required.

Manufacturer Narrative

Conclusion: the complaint was confirmed for a leak from a crack in the bbap40 centrifugal pump.Visual inspection of the returned device showed a crack at the base of the inlet port.For performance analysis 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 inlet port.The medtronic core technologies team was consulted.The complaint device and control devices were submitted for additional analysis.Optical analysis of the complaint device did not show an obvious root cause initiation such as knit line origins (improper mold fill), voids, bubbles, or occlusions in the bulk, foreign material (fm), or impact damage.Fracture lines on a control device caused by a violent upward strike on a solid surface were in similar location to the complaint device port cracks, suggesting the port cracks were caused by an upward stress.Infrared spectroscopy results showed the polycarbonate housing on the complaint device was consistent with a control device; there was no evidence of chemical degradation in the complaint device.Trends for issues with this product are reviewed at quarterly quality meetings.Correction h6 (device code/fdd/annex a): this field has been updated.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: 15625421
• MDR Text Key: 306892726
• Report Number: 2184009-2022-00274
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 20613994647850
• UDI-Public: 20613994647850
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2023
• Device Model Number: BBAP40
• Device Catalogue Number: BBAP40
• Device Lot Number: 223247737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2021
• 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