MAUDE Adverse Event Report: B. BRAUN AVITUM AG - MELSUNGEN DIALOG + 120 V DF+ADIMEA+WAN-BSL+BIC; HEMODIALYSIS SYSTEM

Catalog Number 710200S

Device Problem Calibration Problem (2890)

Patient Problem Hypernatremia (2242)

Event Date 10/08/2016

Event Type  Injury  

Manufacturer Narrative

(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.

Event Description

As reported by the user facility: event # 4: 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.

Manufacturer Narrative

(b)(4).Event 4: 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.

• Brand Name: DIALOG + 120 V DF+ADIMEA+WAN-BSL+BIC
• Type of Device: HEMODIALYSIS SYSTEM
• Manufacturer (Section D): B. BRAUN AVITUM AG - MELSUNGEN; schwarzenberger weg 73-79; melsungen d-34212, ; GM
• Manufacturer (Section G): B. BRAUN AVITUM AG - MELSUNGEN; schwarzenberger weg 73-79; melsungen d-34212, ; GM
• Manufacturer Contact: iris ratke ; buschberg 1; melsungen, 34212 ; GM 34212 ; 661713718
• MDR Report Key: 6061352
• MDR Text Key: 58533972
• Report Number: 3002879653-2016-00033
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2016,10/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 710200S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/13/2016
• Distributor Facility Aware Date: 10/10/2016
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/13/2016
• Date Manufacturer Received: 10/10/2016
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 68 YR
• Patient Weight: 88