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

Model Number	IBP4373
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/08/2024
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, due to renal failure, the patient regularly maintained hemodialysis at the department at 9:00 a.M.On the day of the event, the patient underwent hemodialysis perfusion therapy.After two hours of treatment, it was found that there was an 8 cm (centimeter) long crack between the sealing ring at the artery end of the filter shell and the filter body, and some dialysate extravasated.The dialyzer was used in combination with disposable hemodialysis tubing.Priming was done with a normal result.There were no other defects/damages found on the product where the leak was observed.The patient did not complain of discomfort.The patient was given a 0.9% sodium chloride injection of 300 ml (milliliters) for blood return/recovery as a result of the event.There were no components replaced.The filter was replaced.The treatment was continued after changing the medical equipment.After symptomatic treatment, no abnormalities occurred throughout the dialysis treatment, the dialysis treatment ended successfully, and the patient did not complain of special discomfort.There was an unspecified amount of blood loss.A blood transfusion was not performed.The patient was stable and successfully discharged.

• 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: 20151634
• Report Number: 1000312731-2024-00012
• Device Sequence Number: 19902459
• Product Code: KDI
• UDI-Device Identifier: 08051736004161
• UDI-Public: 08051736004161
• 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): 09/05/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: IBP4373
• Device Catalogue Number: IBP4373
• Device Lot Number: 20233100344
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 09/05/2024
• 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: 50 YR
• Patient Sex: Male