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

Model Number	IBP4371
Medical Device Problem Codes	Defective Component (2292); Biocompatibility (2886); Connection Problem (2900)
Health Effect - Clinical Code	Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	03/05/2025
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, at 8:02 am on (b)(6) 2025, a patient with chronic renal insufficiency-uremia was given hemodialysis treatment using a hemodialysis filter.The extracorporeal circulation line was given a 0.9% sodium chloride 1000 ml (milliliters) pre-filled line.After the air was exhausted, the patient was put on the machine for hemodialysis treatment.At 09:39 p.M., the patient began to experience unbearable muscle spasms in both lower limbs.As advised by the doctor, 50% glucose (20 ml) + 10 ml of 10% calcium gluconate was slowly administered intravenously.The dialyzer was found to be damaged and exuded.The blood was immediately returned, and the dialyzer was replaced to continue dialysis.After returning blood, the patient¿s symptoms were alleviated.The patient¿s original dialysis prescription set the total amount of ultrafiltration at 4 hours of treatment to be 1500 ml.At this time, the machine showed that the total amount of ultrafiltration was 510 ml, but the patient¿s body weight showed that the actual ultrafiltration volume reached 1700 ml.After the patient was on the machine again, the total amount of ultrafiltration was reduced to 800 ml.No blood transfusion was required.

• 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: 21662837
• Report Number: 1000312731-2025-00003
• Device Sequence Number: 8346941
• 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): 03/21/2025

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: 2406000186
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 03/21/2025
• Date Device Manufactured: 06/28/2024
• 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: 64 YR
• Patient Sex: Unknown