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

Model Number BBAP40

Device Problems Contamination (1120); Obstruction of Flow (2423)

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

Event Date 01/03/2023

Event Type  malfunction  

Event Description

Medtronic received information that prior to use of a custom tubing pack and centrifugal pump, the customer reported an issue with the extra-corporeal membrane oxygenation (ecmo) circuit.It was previously primed on 22 dec 2022 and ready for transplant on (b)(6) 2023).The custom tubing pack was checked over and the customer stated that all looked good, and they recirculated for 30 minutes with the heater on with no issues.It was then turned off until closer to handing up the lines and when the device was turned back on it was fine initially but then the customer noticed white foreign material (fm) floating through the circuit and the flows dropped from 4.5lpm at 1700 rpm down to 0.2 lpm.The customer mentioned that the fm looked like pieces of the membrane fibers floating in the bag and nothing else was added to the circuit / prime.The devices were replaced.There was no patient involvement, so no adverse effect occurred.Medtronic received additional information that the health care professional believes that the particles look like membrane fibers and therefore suspect it is related to the maquet oxygenator versus the medtronic products.The foreign material was located floating in the prime solution within the sterile tubing.The material was noted to be floating throughout the entire ecmo circuit, including the centrifugal pump, oxygenator, tubing, and prime bag.The sterile barrier was not sealed when the fm was identified.The centrifugal pump was used in a bio-console 560.The circuit was set up and handled appropriately by trained perfusionists.

Manufacturer Narrative

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.

Manufacturer Narrative

Conclusion: complaint not confirmed against the centrifugal pump for white foreign material (fm) floating through the circuit and decreased flow.The device was not returned for analysis.Medtronic manufacturing quality was consulted.The dhr was reviewed, and no anomalies or deviations in the manufacturing process which would cause or contribute to the reported incident were identified.It is also noted that the balance coating materials (medtronic parts respective generic names according to sdss polyethyleneimine-urea solution, copolymer of vinyl sulphonate, ammonium sulphatoethyl methacrylate and methoxy peg methacrylate, sodium hydroxide, and sodium tetraborate decahydrate, and ro/di/uf water) do not contain white fibers.The root cause could not be verified or determined.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.

• 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: 16276609
• MDR Text Key: 309294637
• Report Number: 2184009-2023-00061
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 00643169855199
• UDI-Public: 00643169855199
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2023
• Device Model Number: BBAP40
• Device Catalogue Number: BBAP40
• Device Lot Number: 223501315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2023
• Date Device Manufactured: 01/06/2022
• 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