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	Cyanosis (1798); Hypersensitivity/Allergic reaction (1907); Arteriosclerosis/ Atherosclerosis (4437); Localized Skin Lesion (4542)
Date of Event	10/15/2024
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, on (b)(6) 2024, the patient underwent hemodiafiltration treatment due to renal failure.On (b)(6) 2024, at 08:30 a.M., the patient was found to have poor distal circulation of four limbs, and the skin was visible plaque.Device adverse event was not ruled out; the treatment was stopped at 09:10, and methylprednisolone sodium succinate for injection 40 mg ivgtt an ti-allergic reaction was used.The patient's skin was cyanotic, and speckles could be seen on the extremities.There was nothing unusual observed on the product prior to use, and there were no other visible defects found on the product at the time of the event.There was no alarm or code that was displayed.The reported product was replaced, and the treatment was completed.There was no blood loss, and blood transfusion was not performed.
Additional Manufacturer Narrative
Additional information: g3 correction: imei code update (removed: e0502 4437 c34398 arteriosclerosis/at), e1(country).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: 20694746
• Report Number: 1000312731-2024-00017
• Device Sequence Number: 17082889
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2024

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: IBP4371
• Device Catalogue Number: IBP4371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 11/16/2024
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 11/18/2024
• 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: 77 YR
• Patient Sex: Female