MAUDE Adverse Event Report: PERFUSION SYSTEMS HMS PLUS INSTRUMENT; ANALYZER, HEPARIN, AUTOMATED

Model Number	30514
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
Medtronic received information that at an unspecified time, this hms plus instrument had failed the act liquid qc test.Use of instrument was unspecified.There was no adverse patient effect reported with this event.
Additional Manufacturer Narrative
Medtronic received additional information that cartridge used was lot#230628144 normal act control lot#229543879 and abnormal act control lot#230945225.Liquid quality controls (qcs) are performed weekly.There was no error code observed, liquid qc was repeated a few times and kept failing on one machine but not the other hms.The control values obtained were act abnormal: 288sec; 384secs;114se cs;346secs;312secs;100secs and act normal:114secs; 100secs.None of these values were used for a case.Additional information h6.2 eval code method (fdm/annex b): this field was updated.Additional information h6.3 eval code result (fdr/annex c): this field was updated.Additional information h6.4 eval code conclusion (fdc/annex d): this field was updated.Device evaluation summary: the reported failing liquid qc issue was verified during service.Service technician spoke with perfusion and asked them to run the eqc and an empty hdr cartridge.Customer reported back that the unit passed eqc but produced an error of ¿cartridge not recognized¿ when running an empty hdr cartridge.The issue was resolved by cleaning the fluid spill found on the top right side of the heat block obscuring the light path of cartridge reading sensors.Cleaned top of heat block to correct problems with cartridge identification.Ran an hdr cartridge and eqc without error.Preventive maintenance was performed as per specification.The instrument was serviced/analyzed in the facility by a field service technician.The instrument did not return to a medtronic facility for service/analysis.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: HMS PLUS INSTRUMENT
• Common Device Name: ANALYZER, HEPARIN, AUTOMATED
• 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: 21918626
• Report Number: 2184009-2025-00582
• Device Sequence Number: 9086371
• Product Code: JOX
• UDI-Device Identifier: 00763000158002
• UDI-Public: 00763000158002
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K101271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2025

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
• Operator of Device: Health Professional
• Device Model Number: 30514
• Device Catalogue Number: 30514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown