MAUDE Adverse Event Report: B. BRAUN AVITUM AG - MELSUNGEN DIALOG A + HE/BIC; HAEMODIALYSIS SYSTEM

Catalog Number 710200L

Device Problem Display Difficult to Read (1181)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information has been requested from the facility and the investigation is on-going at this time.A follow up report will be provided when the evaluation results are available.

Event Description

As reported by the user facility: machine displayed the incorrect uf removal however the patients uf removal was correct.No effect to the patient.Machine alarmed uf rate to low.No patient harm.Additional information by e-mail from customer : patient was set to take off 4.6 kilograms (set goal) and at end of the treatment the machine said it only took off 1.2 - 3.4 kilo deviation; patient's pre-weight (b)(6), patient's post-weight (b)(6); the patient's weigh themselves; patient did not experience any symptoms other than cramping at the end of the treatment which is normal for this patient; returned 300 ml saline to patient to ease cramping; alarm was triggered around 48 mins into tx that said uf rate to low.

Manufacturer Narrative

(b)(4).The facility reported that the dialog+ dialysis machine (sn (b)(4)) displayed the incorrect ultrafiltration (uf) removal although the uf removal from the patient was correct.The patient was set to take off 4.6 kg.At the end of the treatment the machine displayed that it took off only 1.2 kg.The patient's weight before dialysis was (b)(6) and after dialysis (b)(6).The patient did not experience any symptoms, other than cramping at the end of the treatment which is, according to the nursing staff, normal for this patient.He received 300 ml saline to ease the cramping.It was reported that the dialysis machine triggered the alarm uf rate to low about 48 min into therapy.The alarm was acknowledged and the therapy was continued.It was also indicated that several simulated therapies were run and the described situation could not be reproduced.All information and machine data trend files associated with this event were forwarded to the equipment manufacturer b.Braun (b)(4).According to the manufacturer's investigation, the analysis of the data record of the dialog+ dialysis machine showed that at therapy start the uf target was set to 4600 ml by the user.The value was recognized by the controller and the supervisor.Both values were displayed on the screen of the dialog+ machine and actively acknowledged by the user.About 43 min into therapy the controller stopped recognizing the uf volume removed by the uf pump.The supervisor still recorded the uf correctly which can be seen in the data record.In consequence, the correct uf was removed from the patient, but on the screen, the uf value at the time the controller stopped recognizing the uf value was displayed.No alarm was triggered to make the user aware of the situation because the real ultrafiltration was correct.About 9 min thereafter, the warning "uf removal too low" was triggered as described.This warning is triggered, if the actual uf removal is more than 200 ml below the required uf removal at that time.The required and the real uf volume were 1244 ml, but the controller value, taken for the calculation, was 1012 ml.The therapy was continued without any issues.Thirty eight minutes before the end of therapy uf min was activated by the user.This accounts for the fact that the initially set uf goal of 4600 ml was not reached.When the therapy had elapsed and the device switched to reinfusion.The real uf was 4108 ml (supervisor value) and the uf displayed on the screen was 1152 ml (controller value).The comparison between the patient's weight and really removed ultrafiltration show, that there was no deviation.The real uf removal as shown by the supervisor value of the dialog+ machine was 4108 ml.The patient's pre-dialysis weight was (b)(6) and the post-dialysis weight (b)(6).Including the 300 ml saline infused at the end of therapy, this results in a net uf of 4.1 kg.The difference between the real uf (supervisor value) and the displayed uf (controller value) is due to a failure in the software.This failure occurs if every 49 days a variable overflows which takes a second.In this situation the low level controller (llc) stops recognizing the rotation of the up pump if the uf rate is constant.The uf rate constantly oscillates to reach the set uf goal.Therefore, usually a constant value is reached only for some seconds and the situation is resolved quickly.In the current case, the situation was not resolved autonomously because the ultrafiltration rate was always constantly at the upper limit to reach the set uf target until uf min was activated by the user.In summary, the ultrafiltration is removed correctly as monitored by the supervisor, but displayed incorrectly on the screen.If the uf rate would have been changed by the user, the controller (llc) would have restarted calculating the uf volume correctly except the difference for the time during which the software failure was effective.In this situation the real uf volume can exceed the value displayed on the screen of the dialog+ machine.In any case the protective system (lls) will get the correct uf value and generates an alarm (alarm code 1826) before the uf deviation reaches 400 ml.All information concerning this incident has been included in our trend analysis of the product line.A historical review of the customer complaint database, revealed no adverse trends regarding this issue.Nevertheless, this software failure is known by the manufacturer and will be corrected with the next software release.If additional pertinent information becomes available, a follow up report will be submitted.

• Brand Name: DIALOG A + HE/BIC
• Type of Device: HAEMODIALYSIS SYSTEM
• Manufacturer (Section D): B. BRAUN AVITUM AG - MELSUNGEN; schwarzenberger weg 73-79; melsungen, D-342 12; GM D-34212
• Manufacturer (Section G): B. BRAUN AVITUM AG - MELSUNGEN; schwarzenberger weg 73-79; melsungen, D-342 12; GM D-34212
• Manufacturer Contact: iris ratke ; buschberg 1; melsungen, 34212 ; GM 34212 ; 661713718
• MDR Report Key: 5753024
• MDR Text Key: 48293956
• Report Number: 3002879653-2016-00023
• Device Sequence Number: 1
• Product Code: FKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/15/2016,05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 710200L
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/15/2016
• Distributor Facility Aware Date: 05/31/2016
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/15/2016
• Date Manufacturer Received: 08/23/2016
• 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