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

Model Number	710200S
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)
Date of Event	12/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number e2015012.B.Braun medical inc (importer) is submitting this report on behalf of b.Braun avitum ag (manufacturer).This report has been identified as b.Braun avitum internal report # (b)(4).A b.Braun us technician inspected the machine at the user facilty.The treatment trend report for the incident date of (b)(6) 2017 were reviewed.The report indicates the machine did alarm for venous and arterial pressures.The audible alarms were verified to be working when triggered.The investigation is on-going at this time.A follow-up report will be submitted when the investigation results become available.
Event or Problem Description
As reported by the user facility: reported that during a therapy the venous access became dislodged from the patient access and the machine did not alarm.The nurse called paramedics due to blood loss and hypotension.
Event or Problem Description
As reported by the user facility: reported that during a therapy the venous access became dislodged from the patient access and the machine did not alarm.The nurse called paramedics due to blood loss and hypotension.Additional information was received on 2/15/2018.The venous needle dislodged two (2) hours and thirty (30) minutes after the start of therapy.The blood loss was approximately 300-400ml.It was indicated there was no damage at the connector of the vascular access or the bloodline system.
Additional Manufacturer Narrative
Exemption number e2015012.(b)(4).A b.Braun us technician inspected the machine at the user facility.The treatment trend report for the incident date of (b)(6) 2017 were reviewed.The report indicates the machine did alarm for venous and arterial pressures.The audible alarms were verified to be working when triggered.The dialog+ dialysis machine involved in this event was inspected by the b.Braun technician.He reviewed the trend file onsite during the service call and determined that both the venous and arterial alarms were triggered.It was confirmed that there was no malfunction.The dialog+ machine operated as intended.A dialysis machine can detect a venous needle dislodgement if the venous pressure drops below the lower venous pressure limit, as in the current case.If only a small or no pressure change may occur and the venous pressure does not fall below the lower limit, the venous pressure monitor might not detect and alarm a venous needle dislodgement.Therefore, the operator has to monitor the access side carefully.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).These characteristics of a dialysis machine and the consequences are outlined 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.Therefore, the instructions for use of the dialog+ dialysis machine warns the user in chapter 5.3 as follows: - 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.Since there was no malfunction of the dialog+ dialysis machine complained in the current case, no further measures will be initiated.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: DIALOG+®
• Common Device Name: HIGH PERMEABILIT
• Manufacturer (Section D): B. BRAUN AVITUM AG - MELSUNGEN; schwarzenberger weg 73-79; melsungen, D-342 12; GM D-34212
• MDR Report Key: 7214888
• Report Number: 3002879653-2018-00001
• Device Sequence Number: 13486572
• Product Code: KDI
• UDI-Device Identifier: 04046964285608
• UDI-Public: (01)04046964285608
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K083460
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2018
• Report Date (Section F): 03/01/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 710200S
• Device Catalogue Number: 710200S
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/04/2018
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/01/2018
• Initial Date Received by Manufacturer: 01/04/2018
• Supplement Date Received by Manufacturer: 01/04/2018
• Initial Report FDA Received Date: 01/24/2018
• Supplement Report FDA Received Date: 03/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 03/01/2018