MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-09-16 for DIALOG+ HDF-ONLINE INCL. AKKU/ABPM 710507E manufactured by B. Braun Avitum Ag - Melsungen.
[55005520]
(b)(4). The investigation is ongoing at this time. A follow up report will be submitted when the results of the investigation become available.
Patient Sequence No: 1, Text Type: N, H10
[55005521]
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.
Patient Sequence No: 1, Text Type: D, B5
[57842502]
(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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002879653-2016-00028 |
| MDR Report Key | 5957172 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-09-16 |
| Date of Report | 2016-08-19 |
| Date of Event | 2016-04-08 |
| Date Facility Aware | 2016-08-19 |
| Report Date | 2016-10-19 |
| Date Reported to FDA | 2016-10-19 |
| Date Reported to Mfgr | 2016-10-19 |
| Date Mfgr Received | 2016-10-14 |
| Device Manufacturer Date | 2009-06-16 |
| Date Added to Maude | 2016-09-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. IRIS RATKE |
| Manufacturer Street | BUSCHBERG 1 |
| Manufacturer City | MELSUNGEN, 34212 |
| Manufacturer Country | GM |
| Manufacturer Postal | 34212 |
| Manufacturer Phone | 661713718 |
| Manufacturer G1 | B. BRAUN AVITUM AG - MELSUNGEN |
| Manufacturer Street | SCHWARZENBERGER WEG 73-79 |
| Manufacturer City | MELSUNGEN, 34212 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 34212 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIALOG+ HDF-ONLINE INCL. AKKU/ABPM |
| Generic Name | HEMODIALYSIS SYSTEM |
| Product Code | FKJ |
| Date Received | 2016-09-16 |
| Catalog Number | 710507E |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 7 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN AVITUM AG - MELSUNGEN |
| Manufacturer Address | SCHWARZENBERGER WEG 73-79 MELSUNGEN, 34212 GM 34212 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-16 |