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

Model Number	IBP4373
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Dizziness (2194)
Date of Event	07/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, on the day of the event, the blood purification center nurse was treating the patient with a dialyzer.It was stated that during dialysis, the patient experienced dizziness, with blood pressure (bp): 159/94 mmhg and p: 71 times/minute.There was no alarm/error code activated/displayed.Priming was done with a normal result.The reporting physician gave dexamethasone intravenously as a remedial action, and the symptoms were relieved.The issue was also reported to the supplies office.The procedure was continued and completed after the remedial action was done.There was no blood loss, and a blood transfusion was not performed.
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.

• 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: 20055557
• Report Number: 1000312731-2024-00010
• Device Sequence Number: 8117720
• 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): 08/23/2024

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 Expiration Date: 09/30/2026
• Device Model Number: IBP4373
• Device Catalogue Number: IBP4373
• Device Lot Number: 2310000109
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 08/23/2024
• Date Device Manufactured: 10/09/2023
• 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
• Patient Age: 37 YR
• Patient Sex: Female