MAUDE Adverse Event Report: PERFUSION SYSTEMS MOTOR EXTERNAL DRIVE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 560A

Device Problem Mechanical Problem (1384)

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

Event Date 07/29/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary:the reported decoupling and hand crank issue was not verified during service.Motor head decoupling sound began circuit clamped, and hand crank initiated.Patient under went cpr due to no flow.Circuit was moved to new motor drive, and noise continued switched to different (mckay) pump system including circuit to eliminate noise and remedy flow.Performed pm and operational check of base unit and then the motor.Verified indications from base unit were accurate and then confirmed indication of motor.Performed all checks in accordance with all applicable maintenance instructions and manuals with all checks checking within limits.Conclusion: the reported decoupling and hand crank issue was not verified during service.Performed all checks in accordance with all applicable maintenance instructions and manuals with all checks checking within limits.The adverse events were attributed to the cbap40, not the instruments.The service history record was not reviewed as returned product analysis found no evidence of servicing issues with the serviced device.Even though this device was used for 329 hours, per supplemental ifu part number extended use was deemed to not produce undue risk.Trends for issues with this product are reviewed at quarterly quality meetings.Note: this external motor drive was manufactured by plexus this regulatory report is being submitted as part of a retrospective review and remediation per d00953163 as part of a capa action.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 during use of this bio-console instrument, external motor drive and centrifugal pump, the motor head decoupling sound began.The circuit was clamped, and hand crank initiated.The patient underwent cpr due to no flow.The circuit was moved to a new motor drive, and the noise continued.The customer switched to a different manufacturers centrifugal pump system including circuit to eliminate the noise and remedy flow.The customer reported that the patient was not anti-coagulated due to bleeding complications and a clot was evident inside the centrifugal pump.There was no visible damage to the centrifugal pump.The customer stated that the circuit was in use for 329 hours prior to the issue and the flow rate was at 4.5lpm.The customer believes that due to no anti-coagulation, the clot formed over the extended period of use (329 hours).Patient status is unknown along with patient data due to hippa requirements.Additional information: tubing lot#219975232 euroset oxygenator lot# 6362557f36 euroset oxygenator is not a medtronic product.According to our service rep kris askam all hardware was in spec and working correctly.The adverse events were attributed to the cbap40, not the instruments.

• Brand Name: MOTOR EXTERNAL DRIVE
• Type of Device: CONTROL, PUMP SPEED, 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: 17286413
• MDR Text Key: 318805716
• Report Number: 2184009-2023-00818
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 00763000108281
• UDI-Public: 00763000108281
• 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
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 560A
• Device Catalogue Number: 560A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention