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

Catalog Number 710507E

Device Problem Computer Software Problem (1112)

Patient Problem Discomfort (2330)

Event Date 04/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation is ongoing at this time.A follow up report will be submitted when the results of the investigation become available.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(4)): a user in (b)(6) reported that during a therapy with a dialog+ dialysis machine, the to-do-list function was used to remind the user to change the dialysis concentrate during therapy.The warning to remind the user to change the concentrate occurred but reset automatically by the device.Consequently the nurse was not reminded by the device and the concentrate was not changed.The dialysis therapy was finished as scheduled.The following therapy was planned for (b)(6) 2016 in the evening but had to take place in the morning of (b)(6) 2016 because the patient had developed a hyperkalemia and complained about pain throughout the body.The complained sw version is not marketed in the usa.

Manufacturer Narrative

(b)(4).B.Braun (b)(4) became aware of a software error in software (sw) 8.2a of the dialog+ dialysis machine affecting the timer/stop watch function.This timer function only serves as a support to the user to remind of an action that has to be taken by the user.The failure occurs only in sw 8.2a and only in combination with option adimea.In certain conditions and on rare occasions, the warning triggered to remind the user is reset by the machine without user interaction.The user might not be aware that the reminder was triggered at all.The root cause of this failure is a single error in sw 8.2a.If the error occurs, the warning sounds and the yellow light flashes as intended, but the warning is reset by the machine without user interaction.If the timer/stop watch function is used to remind the user of the application or change of a medication during therapy, and the reminder fails, the patient might suffer from consequences dependent on the medication intended to be applied.Since the market introduction of the sw 8.2a in 2010 only one single case was reported recently in germany describing this situation.In this case the concentrate was not changed.The patient did not suffer from any long-term consequences.The failure has been corrected with software version 8.2b.All dialog+ dialysis machines with software 8.2a and option adimea must be updated to software 8.2b.Based on the investigation results of this complaint a voluntary recall had been initiated in the countries where the software version 8.2a of the dialog+ machine in combination with option adimea is marketed.Since the affected software version 8.2a is not marketed in the usa, it is not required to include the usa in this voluntary recall.

• Brand Name: DIALOG+ HDF-ONLINE INCL. AKKU/ABPM
• 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 - MELSUNGEN; schwarzenberger weg 73-79; melsungen, 34212 ; GM 34212
• Manufacturer Contact: iris ratke ; buschberg 1; melsungen, 34212 ; GM 34212 ; 661713718
• MDR Report Key: 5957172
• MDR Text Key: 55005520
• Report Number: 3002879653-2016-00028
• Device Sequence Number: 1
• Product Code: FKJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K083460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/19/2016,08/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 710507E
• 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: 10/19/2016
• Distributor Facility Aware Date: 08/19/2016
• Device Age: 7 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/19/2016
• Date Manufacturer Received: 10/14/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/16/2009
• 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