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 12/01/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).Initial information was received from the facility biomed and he noted that the machine was not involved in the incident after internal investigation.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: the male patient was undergoing dialysis treatment.Dialysis machine triggered a blood pressure alarm and patient was noted to be bleeding; evidence of blood was noted.Patient went into cardiac arrest, cpr was started, emergency technicians arrived on scene to resume care, and then declared his death around 1000 am.

Manufacturer Narrative

(b)(4).On january 13, 2017, b.Braun (b)(4) received a call from a detective of the lake forrest police department requesting information about the functionality of the dialog+ dialysis machine.During this call, b.Braun (b)(4) learned that a male patient was undergoing dialysis treatment.The dialysis machine triggered a pressure alarm and the patient was noted to be bleeding.The patient went into cardiac arrest and cpr was started.Emergency technicians arrived on scene to resume care, and then declared his death around 10:00 am.After a follow up call with the facility biomed, he confirmed that the venous needle had dislodged and the dialog+ dialysis machine (sn (b)(4)) did trigger an alarm.According to his report, he also checked the machine trend data records and confirmed that there was no malfunction of the dialog+ machine.Multiple attempts were made to obtain additional information from the facility about the circumstances around the event as well as patient information, but the customer indicated that the case was under investigation and they were not allowed to disclose additional details.Meanwhile, all information associated with this event was forwarded to the equipment manufacturer b.Braun (b)(4).According to their report, the trend data record was not provided by the facility for further investigation.However, according to report received from the customer biomed, the device trend files were analyzed by the facility technician and a conclusion was made that the machine operated as intended.The manufacturer reports that the dialog+ dialysis machine will detect a venous needle dislodgement event when the venous pressure drops below the lower venous pressure limit.However, if only a small or no pressure change occurs, depending on the circumstances, and the venous pressure does not fall below the lower limit, the venous pressure monitor might not detect the drop and it might not trigger an alarm.Therefore, the user has to carefully monitor the access side of the patient.In addition, the lower alarm limit for venous pressure monitoring should be set as closely to the current value as possible (e.G.20 mm hg).If alarm limits are set automatically, they have to be checked and, if necessary, readjusted manually.These properties of a dialysis machine are referenced in the guideline for safe operation of medical equipment used for hemodialysis treatments (iec/tr 62653 edition 1.0 2012-06) chapter 5.3.1 and 5.3.3.To account for this functionality, the instructions for use of the dialog+ machine provides the following warning to the user (refer to chapter 5.3): risk to patient due to blood loss if cannulas get disconnected or slip out! standard monitoring function of the dialysis machine cannot safely detect that such a situation has arisen! ensure that the access to the patient always remains fully visible during therapy; ensure that cannulas are adequately fixed; regularly check patient access; venous lower limit should preferably be > 0 mmhg.In summary and based on the information received, the dialog+ hemodialysis machine did trigger a low venous pressure alarm and operated as intended.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: 6258665
• MDR Text Key: 65024440
• Report Number: 3002879653-2017-00001
• 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,other,use
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/08/2017,01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 710200L
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/08/2017
• Distributor Facility Aware Date: 01/13/2017
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/08/2017
• Date Manufacturer Received: 01/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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