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

Model Number	IBP4371
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	10/24/2024
Type of Reportable Event	Serious Injury
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, 30 minutes into hemodialysis treatment using a hemodialysis filter, the patient complained of difficulty breathing or dyspnea.The patient was given oxygen and dexamethasone 5 mg (milligrams) bolus intravenously.No alarm was activated.No other defects/damages found on the product.It was five minutes after the dexamethasone was administered, and the patient's dyspnea was still intolerable, so they had to replace the filter on the same day to continue treatment.It resolved the issue and the treatment was completed.There were no blood transfusions.Aside from dyspnea, there was no other patient injury occurred.

• 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: 20746154
• Report Number: 1000312731-2024-00018
• Device Sequence Number: 8614135
• Product Code: KDI
• UDI-Device Identifier: 08051736004147
• UDI-Public: 08051736004147
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/21/2024

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: IBP4371
• Device Catalogue Number: IBP4371
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 11/21/2024
• 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: Required Intervention; Other
• Patient Age: 37 YR
• Patient Sex: Male