MAUDE Adverse Event Report: B. BRAUN AVITUM AG - MELSUNGEN DIALOG+® ; HIGH PERMEABILIT

Model Number 710200S

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Arrest (1762)

Event Date 10/16/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report has been identified as b.Braun (b)(4) internal report # (b)(4).The machine trend file and additional information were requested from the facility.The facility contact indicated they are unwilling to give any information.The investigation is on-going at this time.A follow-up will be submitted when the investigation results become available.

Event Description

As reported by the user facility: patient had a cardiac arrest on the machine during therapy and that in the process of testing the dialysate electrolytes it was discovered that the results where off from what was expected by the customer.It should be noted that the conductivity and temperature where reported to be within tolerance.Patient had cardiac arrest during treatment.The therapy was stopped.The patient was sent to the emergency room and released 48 hours later as reported by the caller.Patient was a (b)(6) year old male who came to the facility for his treatment as scheduled on (b)(6) 2017.Pt weight was (b)(6) kg before treatment with the target wt of (b)(6) kg.The patient had a cvc for dialysis.No labs to report as labs are done on a monthly basis and the week of the event was not a "lab week".The dialysis order for the patient on (b)(6) 2017 was as follows: 240 mins, blood flow rate 300ml/hr, dialysate flow rate 600ml/hr, temp 36 degrees, 3k bath, heparin bolus 1000units, heparin maintenance 1000 units/hr, bicarb 40.The patients vitals before cardiac arrest at the start of his dialysis treatment were bp-180/66 sitting, pulse-65, temp-96 degrees f.The patient's vitals right before cardiac arrest were bp-101/70 hr-91.Patient found to have no pulse.Cpr was started.During cpr blood was infusing back to patient.Compressions and breaths lasted approximately 2 mins.No meds were given.The patient regained a heart rate and became alert yet not himself.The patient was taken to the hospital and stayed there until (b)(6) 2017 when he was discharged and brought back to the dialysis facility where he received another dialysis treatment.He was discharged from the hospital because the hospital does not have the ability to give dialysis treatments.They were able to complete his treatment but could not get him to a dry state as he was not stable.The patient left the facility and was taken to (b)(6).The patient has not returned to the dialysis center as of yet.

Manufacturer Narrative

(b)(4).The b.Braun field service regional leader contacted the facility to request a visit to the facility to evaluate the machine.The facility biomed reported that he did not feel that b.Braun needed to come in and look at the machine.All treatment parameters were well within specs.He would have to get the approval through risk management and his management for a b.Braun technician to come in.In addition, the biomed also reported that he has received the field utility stick to download the trend file on the specific therapy.Later b.Braun was informed that the customer is not going to share any additional information and is not going to be providing the trend data.The dialog+ dialysis machine complained about was inspected by the customer's technician.He confirmed that there was no malfunction.Dialysis machines in general monitor the total electrolyte content of the dialysis fluid by measuring the conductivity.The dialog+ machine measures and monitors the bicarbonate conductivity before the bicarbonate solution is mixed with the acidic component and the overall conductivity of the dialysis fluid.The bicarbonate conductivity range is 2-4 ms/cm or 4-7 ms/cm dependent on the presetting in the technical service mode.The range of the overall conductivity is 12.5-16 ms/cm in the dialysis fluid.The tolerance of the conductivity is ±0.2 ms/cm.These ranges are indicated in the instructions for use of the dialog+ machine.The bicarbonate and the overall conductivity are checked during the preparation phase of the dialysis machine and continuously monitored during therapy and disinfection.If there might be a failure during the preparation phase of the dialysis machine, this is indicated and the preparation phase is stopped and a therapy start is not possible.A failure during therapy is alarmed and the machine switches into patient-safe mode.During disinfection the concentration and the temperature of the disinfectant is continuously monitored.If the specified limits are exceeded, the dialysis machine displays a warning.All warnings are listed and distinctly marked in the disinfection history.It is also indicated when all disinfection steps are completed.After each disinfection cycle, the user is requested to check the disinfection history and to confirm it actively.Based on the function principle of a dialysis machine to monitor the electrolyte content of the dialysis machine by monitoring the conductivity of the dialysis fluid, the instructions for use of the dialog+ machine shows the following warning in chapter 5.4: risk to the patient due to incorrect composition of dialysate: ensure that the correct concentrates are provided for the intended therapy.Only use concentrates whose printed use-by date has not expired.Only use originally closed and intact concentrate containers.Observe storage information on concentrate containers.It is recommended to use concentrates produced by b.Braun medical inc.When concentrates are used that are not produced by b.Braun medical inc.The correct mixing ratio and composition has to be checked on the concentrate label.In addition, the instructions for use inform that the physician in charge is responsible for determining the concentrates to be used.Since there was no malfunction or product deviation of the dialog+ dialysis machine complained about, no further actions will be taken.The cause of the patient's cardiac arrest cannot be determined.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: DIALOG+®
• Type of Device: HIGH PERMEABILIT
• Manufacturer (Section D): B. BRAUN AVITUM AG - MELSUNGEN; schwarzenberger weg 73-79; melsungen, D-342 12; GM D-34212
• MDR Report Key: 6983820
• MDR Text Key: 90627669
• Report Number: 3002879653-2017-00014
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 04046964285608
• UDI-Public: (01)04046964285608
• Combination Product (y/n): N
• PMA/PMN Number: K083460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/01/2018,10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 710200S
• Device Catalogue Number: 710200S
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/01/2018
• Distributor Facility Aware Date: 10/24/2017
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/01/2018
• Initial Date Manufacturer Received: 10/24/2017
• Initial Date FDA Received: 10/27/2017
• Supplement Dates Manufacturer Received: 10/24/2017
• Supplement Dates FDA Received: 03/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 89