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 Codes	Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908); Itching Sensation (1943); Rash (2033)
Date of Event	05/10/2025
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, on (b)(6) 2025, at 08:35, the patient underwent hemodiafiltration.Initial vital signs were blood pressure 126/81 mmhg (millimeters of mercury) and pulse 69 bpm (beats per minute).At 08:59, the patient exhibited an allergic reaction to the hemodiafilter, and the patient reported pruritus/itching in both palms.Per the physician's order, the substitution fluid was discontinued, but the symptoms did not improve.At 09:03, generalized pruritus and rash developed, worsening from the initial presentation.As an initial disposition, corresponding anti-allergy treatments were given.Oxygen inhalation and intravenous administration of 5 mg (milligrams) of dexamethasone were administered per physician's order, with no improvement.The extracorporeal circuit was disconnected per the physician's order, and 25 mg of promethazine was administered intramuscularly.Vital signs at this time were blood pressure 156/94 mmhg, pulse 80 bpm, and spo2 (peripheral capillary oxygen saturation) 98%.Subsequently, 50 ml (milliliters) of 10% glucose injection and 10 ml of 10% calcium gluconate were administered intravenously.The patient's condition gradually improved, and observation continued.At 10:10, the patient was reconnected to the machine per the physician's order, and the extracorporeal blood volume was returned and reinfused on the machine.Subsequent treatment was uneventful, and vital signs remained stable.Therewas no blood loss.There were no blood transfusions.

• 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: 22206844
• Report Number: 1000312731-2025-00006
• Device Sequence Number: 20750032
• 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,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2025

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: IBP4371
• Device Catalogue Number: IBP4371
• Device Lot Number: 2407000056
• 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: 05/29/2025
• Initial Report FDA Received Date: 06/13/2025
• Date Device Manufactured: 07/03/2024
• 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: 39 YR
• Patient Sex: Unknown