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	09/18/2024
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 does not give good results, as it does not fill the cartridge to the right level.Use of instrument was unspecified.There was no adverse patient effect reported with this event.
Additional Manufacturer Narrative
Additional information b5: medtronic received additional information that a situation where the 6 channels had different amounts of blood occurred with the heparin dose response (hdr) cartridges, as well with different color cartridges.The lot numbers of the cartridges are unknown, but this happened with several different lots.Quality control is performed every week for every color of cartridge.There was no error code, other than the code saying there was too big of a gap between 2 hdr channels.The dose of heparin was not retained on the tests that were problematic.Device evaluation summary: the reported issue of the instrument not give good results, as it did not fill the cartridge to the right level was verified during service.No physical issues were observed.The service technician was able to duplicate the reported issue.The issue was resolved by cleaning and lubricating all moving assemblies and cleaning the instrument.The instrument was then successfully powered on and it completed the power on self test (post) with no issues.The instrument passed all function tests without any issues or failures.Preventive maintenance was performed per specifications.Correction g4.4 (pma / 510(k) #): this field has been updated.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: 20255287
• Report Number: 2184009-2024-00548
• Device Sequence Number: 8014103
• Product Code: JOX
• UDI-Device Identifier: 00763000158002
• UDI-Public: 00763000158002
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K111339
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2024

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
• Operator of Device: Health Professional
• Device Model Number: 30514
• Device Catalogue Number: 30514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2019
• 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