MAUDE Adverse Event Report: BELLCO SRL CLEARUM HS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SE

Model Number	IBP4373
Medical Device Problem Codes	Leak/Splash (1354); Protective Measures Problem (3015)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted the filter was visible during treatment, and blood leakage was observed from the bundle.The reported issue was confirmed.The most likely cause could not be established from the information available.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.
Event or Problem Description
According to the reporter, fifteen minutes to one hour after the start of the hdf (hemodiafiltration) treatment, blood leakage was observed within the reported filter.This was not associated with an hrf (hemodiafiltration reinfusion) filter.A blood leakage (bld) alarm was triggered after thirty minutes.There was nothing unusual observed on the device prior to use.No other defects or damages were found on the product where the leak was observed.Priming was done with normal results.No other products were being utilized with the device.As a result, the extracorporeal kit and dialyzer had to be replaced with a new one from the same product id (identifier) and lot number on the day of the event, without returning blood to the patient.The treatment was completed after the remedial action.The patient was administered a drug due to the event.A total of 300 milliliters (ml) of blood was lost, but no blood transfusion was performed.
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.

• Brand Name: CLEARUM HS
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SE
• 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21632596
• Report Number: 1000312731-2025-00002
• Device Sequence Number: 7489774
• Product Code: KDI
• UDI-Device Identifier: 08051736004161
• UDI-Public: 08051736004161
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K193542
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: IBP4373
• Device Catalogue Number: IBP4373
• Device Lot Number: 2409000134
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 04/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown