MAUDE Adverse Event Report: BELLCO SRL CARPEDIEM; PEDIATRIC HEMODIALYSIS SYSTEM

Model Number	IB7010250
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
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
According to the reporter, after the machine was turned on, the machine had a display failure, and the customer reported a burning smell as well.There were no labeling and/or packaging issues.The service event was not an out-of-box failure.There were no alarms activated.There was no alleged deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of the product during the service and repair call or event.There was no patient involvement.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the device screen was found to be damaged.The issue was resolved by replacing the liquid clear display (lcd) screen.It was reported that the device was smoking and there was an issue with the devices display.The reported issues were confirmed.The most likely cause was traced to a component failure.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality 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.
Additional Manufacturer Narrative
Additional information: b5, g3 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
According to the reporter, after the machine was turned on, the machine had a display failure, and the customer reported a burning smell as well.Nothing unusual observed on the device prior to use.There were no labeling and/or packaging issues.The service event was not an out-of-box failure.There were no alarms activated.There was no alleged deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of the product during the service and repair call or event.Besides the reported issue, there were no other visible defects/damages found on the product at the time of the event.As a remedial action, the machine was pulled out of use, and repair was scheduled there was no patient involvement.

• Brand Name: CARPEDIEM
• Common Device Name: PEDIATRIC HEMODIALYSIS SYSTEM
• Manufacturer (Section D): BELLCO SRL; v camurana 1; mirandola,mo 41037 ; IT 41037
• Manufacturer (Section G): BELLCO SRL; v camurana 1; mirandola,mo 41037 ; IT 41037
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22828096
• Report Number: 1000312731-2025-00014
• Device Sequence Number: 14560836
• Product Code: QIR
• UDI-Device Identifier: 08051736003652
• UDI-Public: (01)08051736003652
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: DEN180055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/08/2025

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: IB7010250
• Device Catalogue Number: IB7010250
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 09/02/2025; 10/07/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 09/03/2025; 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown