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	Abdominal Pain (1685); Anaphylactic Shock (1703); Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Anaphylactoid / Anaphylaxis (2218); Cough (4457)
Date of Event	08/22/2024
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, a patient with uremia for many years was treated with continuous hemodialysis.On the day of the event, the patient routinely came to the hospital for dialysis, and the dialysis filter and tubing were normal.Priming was done with a normal result, and an anticoagulant was administered.The dialysis started at 7:33 am, temperature 36.5°c, heart rate 75 beats/min, respiratory rate 18 beats/min, and blood pressure (bp) 140/93 mmhg.At 8:10 am, the patient suddenly presented with chest tightness and an obvious cough without obvious inducement.Considering the patient's biocompatibility of the high molecular material of the dialyzer, dialysis was immediately stopped, and the patient was given blood pressure and oxygen saturation.During this period, the patient did not come out.Considering anaphylactic shock, the patient was immediately given dexamethasone sodium phosphate injection (5mg) via intravenous push according to the doctor's instructions.The heart rate was 62 beats/min.At 08:14, blood pressure was measured at 79/58 mmhg, temperature 36.5°c, p90 beats/min, respiratory rate 18 breaths/min.The patient complained of abdominal pain, which was severe after inrush.The doctor ordered an intravenous drip of 0.9% ns 200 ml to be administered within five minutes.After app eal, the symptoms were treated, and the patient's chest tightness and cough were improved as compared to before.According to the doctor's instructions, the reported product was replaced after the blood was returned to continue the dialysis.At 8:20 a.M., the blood pressure was 96/68 mmhg.Under oxygen inhalation, the oxygen content was 80%, p90 times/bp103/75 mmhg.At 8:30 a.M., the patient¿s vital signs were stable, and the rest had no obvious discomfort symptoms.The dialysis treatment was successfully completed.Dialysis lines were the reported concomitant device.There was no reported alarm/error code activated or displayed.Besides the reported issue, there were no other visible defects or damages found on the product at the time of the event.There was no blood loss, and blood transfusion was not performed.After observation for half an hour, the patient was safe and got out of the hospital.

• 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: 20246882
• Report Number: 1000312731-2024-00014
• Device Sequence Number: 7312764
• 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): 09/18/2024

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
• Device Lot Number: 2311000313
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 09/18/2024
• Date Device Manufactured: 11/28/2023
• 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; Other
• Patient Age: 55 YR
• Patient Sex: Male