MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-10-27 for DIALOG + 120 V DF+ADIMEA+WAN-BSL+BIC 710200S manufactured by B. Braun Avitum Ag - Melsungen.
[58535401]
(b)(4). The machine data log trend files have been forwarded to the manufacturer, and 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
[58535402]
As reported by the user facility: event # 5: reports four patients were hospitalized for high sodium level after treatment. Upon further follow-up with the reporting facility, it was indicated that a total of five patients were impacted; four of those patients were hospitalized.
Patient Sequence No: 1, Text Type: D, B5
[62413848]
(b)(4). Event 5: customer reported that five patients suffered from hypernatremia after being treated with the dialog+ dialysis machine (sn (b)(4)). According to the report, four of the five patients were hospitalized. A b. Braun technician visited the facility to service the machine. According to his service report, he determined that the end conductivity sensor controller (endlf) and the conductivity sensor supervisor (endlf-s) values measured by the dialog+ machine deviated by +3. 2 ms/cm and +3. 6 ms/cm, respectively, from the actual value measured with the respective external meter. The permitted tolerance is +/- 0,2 ms/cm. The technician proceeded to properly calibrate the endlf and the endlf-s and the dialog+ machine operated again as intended. All information and machine trend files associated with these events were forwarded to the equipment manufacturer b. Braun (b)(4). According to their report, two independent conductivity sensors can not drift in the same direction in the same order of magnitude by itself. As a result, the manufacturer concludes that there must have been a failure during the previous calibration of the sensors in the course of a technical intervention. The trend data provided by the customer was analyzed, but it did not give any additional information, since the recorded conductivity values were based on the actual calibration. According to the manufacturer, the calibration of the conductivity sensors is described in detail and comprehensively in chapter 4. 8. 3. 9 of the service manual. Only trained personnel are allowed to service the dialog+, (i. E. Repair, maintenance, software installation, firmware update, retrofitting and commissioning of the dialog+ machine). Servicing must only be performed with proper tools, calibration equipment and be in accordance with the most recent revision of this service manual/technical information, which must be clearly understood. In this specific case, the information related to the procedure of the calibration and the equipment used was requested, but it was not provided by the facility. A review of customer biomeds training records shows that the facility biomed was trained by b. Braun (b)(4) on the technical requirements of the dialog+ hemodialysis machine. Based on the results of this investigation the manufacturer concludes that the patients hypernatremia was caused by an incorrect calibration of the dialog+ dialysis machine. 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. If additional pertinent information becomes available a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002879653-2016-00034 |
| MDR Report Key | 6061498 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-10-27 |
| Date of Report | 2016-10-10 |
| Date of Event | 2016-10-08 |
| Date Facility Aware | 2016-10-10 |
| Report Date | 2016-12-13 |
| Date Reported to FDA | 2016-12-13 |
| Date Reported to Mfgr | 2016-12-13 |
| Date Mfgr Received | 2016-10-10 |
| Date Added to Maude | 2016-10-27 |
| 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 D-34212, |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIALOG + 120 V DF+ADIMEA+WAN-BSL+BIC |
| Generic Name | HEMODIALYSIS SYSTEM |
| Product Code | FKJ |
| Date Received | 2016-10-27 |
| Catalog Number | 710200S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN AVITUM AG - MELSUNGEN |
| Manufacturer Address | SCHWARZENBERGER WEG 73-79 MELSUNGEN D-34212, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2016-10-27 |