MAUDE Adverse Event Report: B. BRAUN AVITUM AG DIALOG+®; KDI-DIALYZER, HIGH PERMEABILIT

Catalog Number 7102072

Device Problem Calibration Problem (2890)

Patient Problems Hypernatremia (2242); Discomfort (2330)

Event Date 11/01/2022

Event Type  malfunction  

Event Description

As reported by the user facility: patients have been complaining of being extremely thirsty during dialysis treatment and some feel unwell.Patients drinking more fluid than usual because of extreme thirst.Two patients experienced difficulty in breathing hence required them to come for an extra session of dialysis.This report is for event #13.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical inc.We received a report of 11 patients complaining of extreme thirst and/or feeling unwell during dialysis therapy.Two patients experienced difficulty of breathing.These patients came for additional dialysis treatment.No further medical intervention was needed.The dialysis therapies took place on four different machines with serial numbers (b)(4).All of the affected devices were isolated and inspected by a local b.Braun's biomedical technician.Inspection revealed that there was a deviation in the final conductivity of approximately 2 ms/cm in the machines concerned.The consequence of this deviation is that the patients were treated with a higher sodium concentration in the dialysis fluid than intended, thus explaining their thirst.Analysis of the service reports of the affected machines showed that one external contract technician had previously calibrated the temperature and conductivity sensors on these machines.In order to find the root cause of the deviation, the technician's measuring equipment was sent to a testing laboratory for verification.The laboratory's test showed no deviation of the measuring device which could result in a conductivity deviation of approximately 2 ms/cm.For further root cause analysis a technician of the global technical service of b.Braun headquarter, melsungen, germany, was sent to australia to verify all machines in the respective dialysis center.For each machine which was previously serviced by the external contract technician a check and recalibration was performed.The check of the affected machines by the global technical service of b.Braun headquarter confirmed that the external contract manufacturer had set a wrong value when calibrating the conductivity sensors.To avoid a recurrence, the external contract technician was retrained on site by the headquarters' global technical service technician.Generally, each dialysis technician servicing b.Braun machines is certified by training.Calibration of conductivity and temperature sensors is described and explained in detail in the technical service manual and within the technical training course for certification.Since check and recalibration by the headquarters' global technical service technician no further abnormalities occurred.Approximately, 900 treatments are performed per machine per year.This results in 50.400 treatments at an installed base of 56 machines in australia in one year and 151.200 treatments in three years.Approximately, 900 treatments are performed per machine per year.This results in 112.788.900 treatments at an installed base of 125.321 dialog+ machines worldwide in one year and 338.366.700 treatments worldwide in three years.No similar event occurred outside australia in the last three years.Thus, the incident rate of similar events outside australia is 0,0 %.The incident rate worldwide, including australia, is 0,00000384 %.

• Brand Name: DIALOG+®
• Type of Device: KDI-DIALYZER, HIGH PERMEABILIT
• Manufacturer (Section D): B. BRAUN AVITUM AG; schwarzenberger weg 73-79; melsungen, 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN AVITUM AG; schwarzenberger weg 73-79; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 16723136
• MDR Text Key: 313652298
• Report Number: 3002879653-2023-00004
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7102072
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2022
• Initial Date FDA Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1