MAUDE Adverse Event Report: B. BRAUN AVITUM AG - MELSUNGEN DIALOG+ HDF-ONLINE; HEMODIALYSIS SYSTEM

Catalog Number 7102072

Device Problem Temperature Problem (3022)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The dialog+ dialysis machine was inspected by a b.Braun technician on-site.A therapy was simulated, but the situation described by the customer was not reproducible.There was no malfunction during the simulated therapy.For comprehensive investigation the device was returned to the manufacturer.The technical inspection of the returned dialog+ dialysis machine including its electronic hardware, its sensors and actuators did not show any product deviation or malfunction.A therapy simulation using the parameter settings used in the complained therapy, ran without any issue.The data record of the dialog+ machine was analyzed again.It showed that the balance chamber membranes and valves stood still from 2.5 hrs into therapy until the therapy was terminated by the user 45 min later.Consequently, the balance circuit was disconnected from the dialysis fluid processing circuit (df-circuit).There was no flow of dialysis fluid from the df-circuit to the balance circuit to which the patient is connected.Since the technical inspection of the machine did not show any product deviation, multiple attempts were made to reproduce the complained situation.It was not reproducible.This lead to the only conclusion that the standstill of the balance chamber membranes and the valves was caused by a deadlock in the software.Due to the separation of the balance and the df-circuit, no dialysis fluid was fed into the balance circuit, but the ultrafiltration pump continued operating.As a consequence, no haemodiafiltration took place, but isolated ultrafiltration.Since the fluid input and output into in balance circuit it balanced to reach the ultrafiltration target set by the user, the patient reaches his ultrafiltration target , but in this case with a reduced solute removal in a single therapy.In case of an isolated ultrafiltration, the fluid extracted from the blood is not diluted by fresh dialysis fluid or substitution fluid.Therefore, the color of the effluent might be brownish as described by the customer.In the df-circuit separated from the balance circuit, the dialysis fluid circulated.The heater temperature was not updated due to the software deadlock, this parameter is updated with the balance chamber cycle.Consequently, the heater operated with a constant output resulting in a heating-up of the dialysis fluid circuit.As a result, the bicarbonate cartridge, part of the df-circuit was heated up as described by the customer.An overheating of the dialog+ machine is prevented by respective fuses.Since the balance circuit is disconnected from the df-circuit in the described situation, it is excluded that heated-up dialysis fluid can reach the patient.The switching off of the dialog+ machine after the therapy resolved the deadlock.As outlined above, there is no risk for patient, user or third party.The dialog+ dialysis machine is in use since in 2009.During this time about 113.5 million therapies had been performed and no similar case is known.Therefore, this case is assessed as single case and no further measures will be initiated.The dialog+ machine was released for service again and was returned to the customer.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(4)): it was reported by a customer in france that the dialog+ dialysis machine triggered a blood leak alarm.When the nurse checked the dialysis machine, she noticed that the dialysate was brown and the bicarbonate cartridge was hot.She disconnected the patient from the machine.There were no consequences for the patient.As soon as the blood leak alarm appeared, the nurse felt the high temperature on the bicarbonate cartridge and the patient was disconnected quickly.

• Brand Name: DIALOG+ HDF-ONLINE
• Type of Device: HEMODIALYSIS SYSTEM
• Manufacturer (Section D): B. BRAUN AVITUM AG - MELSUNGEN; 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: irmtrud jaeckle-meyer ; buschberg 1; melsungen, 34212 ; GM 34212 ; 561713726
• MDR Report Key: 6039651
• MDR Text Key: 57979315
• Report Number: 3002879653-2016-00026
• Device Sequence Number: 1
• Product Code: FKJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K083460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/19/2016,06/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/19/2016
• Distributor Facility Aware Date: 07/21/2016
• Device Age: 2 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/19/2016
• Date Manufacturer Received: 06/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1