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

Catalog Number 710200L

Device Problem Use of Device Problem (1670)

Patient Problem Cardiac Arrest (1762)

Event Date 01/20/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).The machine trend file and 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: customer reported that patient had died while receiving dialysis treatment.A bbraun technician spoke to the hospital biomed and learned that the incident occurred around 4pm.The biomed reported that he did not have details about the incident.A follow up call was made with the facility risk management.Risk management representative indicated that the patient suffered blood loss due to the venous needle coming dislodged from the access site.She did not know how much blood was lost.She indicated that cpr was administered to the patient, but the patient died on site.The dialysis machine was sequestered, waiting for bbraun to conduct a machine inspection.

Manufacturer Narrative

(b)(4).Customer facility reported an incident related to the death of a patient, while receiving dialysis therapy on the dialog+ dialysis machine (sn (b)(4)).According to the customer's report, the patient started her hemodialysis therapy on (b)(6) 2017 at 10:39 am with a pre-dialysis weight of (b)(6).The dialog+ hemodialysis machine was next to the patient's bed.There was no family or visitor present.The patient was alert, oriented and not restless, but it was noticed that she moved the blanket onto her chest frequently during this treatment.The facility reported that the nurses check the patients every 15 minutes during therapy.About two hours into therapy, the nurse was last in the patient's room.The patient was sitting upright in bed talking on the phone.At this time the catheter connection was intact and the patient was normotensive.About 2-5 minutes after the nurse had left the patient's room, she heard a noise.The patient had called out or screamed.When the nurse ran into the room, she noticed the blood on the floor and the patient remained in the bed.It was noticed at that time that the venous access was detached from the blood line set.The luer-lock connectors of the blood line and the catheter were not cracked nor did they appear broken.A rapid response team was immediately at the patient's side, which quickly escalated to code blue team assisting to save the patient's life.Fluids were administered to the patient before the pulse stopped.The patient lost about 2 l of blood within approximately 2.5 min.Cpr started 13:14 pm and was terminated at 13:45 pm.The facility reported that no alarms were triggered by the dialog+ machine when the pressure dropped due to the disconnection of the venous blood line from the catheter.A b.Braun (b)(4) technician was sent to the facility to inspect the machine.According to his report, the technical inspection of the dialog+ dialysis machine did not show any product deviations or malfunctions.The dialog+ hemodialysis machine operated as intended.All information associated with this event was forwarded to the equipment manufacturer b.Braun (b)(4).Also submitted to (b)(4) was the machine trend file associated with this specific therapy.According to the manufacturer, the analysis of the data record of the dialog+ machine showed that 2 hours 20 minutes into therapy the alarm "venous pressure - lower limit - check access" was triggered caused by a sudden drop of the venous pressure from about +158 mmhg to about +40 mmhg.This pressure drop was most probably caused by the disconnection of the venous blood line from the patient's permanent cvc.As a consequence of the alarm, the dialysis machine stopped the blood pump, closed the safety air clamp (sakv) and switched into bypass mode (patient-safe condition).The time between the pressure drop and the alarm and the stop of the blood pump was 5 seconds.During this time the blood loss was calculated to be 33 ml.Twenty-two seconds later the alarm was muted and acknowledged actively by the patient/user by pressing the aq key twice.The analysis of the data trend shows that the machine was started again actively by the patient/user.The evaluation of the trend data record of the dialog+ dialysis machine correlates chronologically with the customer's description of the event.It shows the following sequence of events: the therapy started at 10:39; a drop of the venous pressure at 12:59 lead 5 seconds later to the alarm "venous pressure - lower limit - check access"; as a consequence of the alarm, the blood pump stopped, the safety air clamp (sakv) closed and the device switched into bypass; another 22 seconds later the alarm was muted and acknowledged actively by the patient/user by pressing the aq key twice; cpr was started 14 minutes later.In conclusion, the investigation showed that there was no product deviation.The dialog+ dialysis machine alarmed the drop in the venous pressure as intended, the blood pump stopped, the sakv closed and the machine switched into bypass.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 A + HE/BIC
• Type of Device: HEMODIALYSIS 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: 6275676
• MDR Text Key: 65688789
• Report Number: 3002879653-2017-00002
• Device Sequence Number: 1
• Product Code: FKJ
• UDI-Device Identifier: 040469636
• UDI-Public: (01)040469636
• 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: health professional,user faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 03/27/2017,01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 710200L
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/27/2017
• Distributor Facility Aware Date: 01/20/2017
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/27/2017
• Date Manufacturer Received: 01/20/2017
• 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): Death; Other; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 63