MAUDE Adverse Event Report: PERFUSION SYSTEMS 560 BIO-CONSOLE BASE UNIT; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 560B

Device Problems Device Alarm System (1012); Pumping Problem (3016)

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

Event Date 03/13/2023

Event Type  malfunction  

Event Description

Medtronic received information that during use of a bio-console 560 base unit, it was reported that there was an rpm drop error. after running 11 hours the rpm dropped from 2600 rpm to 2400 rpm.The rpm drifted up and down about 100-800rpm.The use of the instrument was unspecified.There was no adverse patient effect associated with this event.

Manufacturer Narrative

Device evaluation:the reported rpm drop error was verified during service.Service technician performed test 1: rpm (set rpm at 2700 rpm) fs-50:2l.After 3 minutes it dropped to 2620.After 16 minutes it dropped to 2580, after 1 hour 2 minutes it dropped to 2600, after 18 hours 50 minutes it dropped to 2450.The rpm knob measurements were checked.Rpm knob at the off position, the meter reading was 26.92 ohms (50).Rpm knob at the maximum position ,the resistance was 5451 ohms(4500-5500).Motor controller power supply calibration rpm knob at the zero position.Dmm reading was 4.550vdc(4.550v +/-.001v).Rpm performance check :service technician turned the console rpm knob until the ui digital rpm display indicated 2500 rpm.Tachometer and terminal read 2500 rpm ± 125 rpm.The base unit rpm display read 2500 rpm ±125 rpm.Service technician performed test 2: rpm (set rpm at 3000 rpm) fs-50:2l.Rpm (set rpm at 3000 rpm) fs-50:2l.After 0 hours 13 minutes dropped to 2850.After 0 hours 14 minutes dropped to 2810.After 0 hours 13 minutes dropped to 2850.After 0 hours 29 minutes dropped to 2770.After 0 hours 50 minutes dropped to 2680.After 1 hour 01 minutes dropped to 2720.Service technician changed the assy, 560 m/p module and performed test 3: rpm (set rpm at 3200 rpm) fs-50:2l.After 0 hour 11 minutes rpm keep was at 3020 rpm.After 2 hours 30 minutes rpm keep was at 3020 rpm.Service technician performed test 4: rpm (set rpm at 3000 rpm) fs-50:2l.Rpm (set rpm at 3000 rpm) fs-50:2l.After 0 hour 30 minutes rpm keep was at 3000 rpm.Service technician performed test 5: rpm (set rpm at 2600 rpm) flow:3.37l.Rpm (set rpm at 2600 rpm) flow: 3.37l.After 1 hour 20 minutes rpm keep was at 2600 rpm.Preventative maintenance was performed per specifications.Note the instrument was not returned to medtronic facility but was serviced by field service technician medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Additional information for the device evaluation: the issue will be resolved by replacing the assembly 560 bio-console mp module.Pr eventative maintenance will be performed per specifications.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: 560 BIO-CONSOLE BASE UNIT
• 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: 19077413
• MDR Text Key: 340683139
• Report Number: 2184009-2024-00165
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K080824
• 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: 05/23/2024

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: 560B
• Device Catalogue Number: 560B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/10/2024
• Supplement Dates Manufacturer Received: 05/12/2024
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2006
• 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