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

Model Number IBP4370

Device Problems Coagulation in Device or Device Ingredient (1096); Biocompatibility (2886)

Patient Problems Low Blood Pressure/ Hypotension (1914); Local Reaction (2035); Discomfort (2330); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/27/2023

Event Type  Injury  

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

According to the reporter, 15 minutes after the start of rrt (renal replacement therapy), allergic symptoms were observed (significant decrease in blood pressure, significant change in white blood cell count and platelet count), coagulation in the circuit or column, marked residual blood and etc.The patient also had chest discomfort.Qb (blood flow rate) was 200 ml/minute, qd (dialysate flow rate) was 500 ml/minute and qf (infusion flow rate) was 1666 ml/minute.It was stated that competitor's product (cta coating) was used before switching to the filter.There were no previous implementation conditions or changes made at the start of the use of the device.There was no information on alarms during use or no alarms were activated.Initial dose of 300mg anticoagulant was administered to the patient.There was nothing unusual observed on the device prior to use, no damages were noted on the product and priming was done with normal result.There were no laboratory tests performed.After fluid replacement, the condition was alleviated and the patient was monitored for 30 minutes, however, there was no increase in blood pressure.The anticoagulant nafamostat or (nm) was suspected and hdf (hemodiafiltration which was a hemodiafilter for hemodialysis) membrane was replaced.After that, the blood pressure increased and chest discomfort disappeared.They continued to used 30mg of anticoagulant drug (nm) but no symptoms were observed.Fluid replacement and hdf membrane replacement (changed to a different hdf coating on the same day of the event) were the intervention done and no other intervention was provided to the patient.Treatment was completed.The patient did not have a history of allergic reaction during dialysis.There was no blood leakage/loss and blood transfusion was not performed.

• Brand Name: CLEARUM HS
• Type of Device: 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: 17585838
• MDR Text Key: 321563758
• Report Number: 1000312731-2023-00004
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 08051736004130
• UDI-Public: 08051736004130
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K193542
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IBP4370
• Device Catalogue Number: IBP4370
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention