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

Model Number 710200L

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/04/2022

Event Type  malfunction  

Event Description

As reported by the user facility: it was reported that a venous needle dislodged without alarm during treatment.Staff reported the machine never alarmed and blood pump did not stop.The trend file was captured and was provided for evaluation.Upon review of the trend data, it was confirmed that the device did alarm for venous pressure.A safety inspection performed on the device showed no issues.The patient involved in the incident required a blood infusion and was sent to the emergency room for treatment after the event.The customer also confirmed via additional inquiry there was no serious injury and no patient harm was reported after the incident.Estimated time of the occurrence is between one hour and thirteen minutes and one hour and fourteen minutes into the infusion.

Manufacturer Narrative

This report has been identified as b.Braun medical, inc.Internal report number (b)(4).The device involved has not been received for evaluation and the investigation is ongoing at this time.A follow-up will be submitted when the investigation results become available.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).It was reported that the venous needle dislodged during a therapy with a dialog+ dialysis machine.The venous needle either slipped out or was pulled accidently by the patient.According to the information received by the facility, the dialysis machine did not alarm, and the blood pump did not stop.After the venous needle dislodgement, the therapy was not resumed and the patient involved in the incident was sent to the emergency room for treatment after the event, required a blood transfusion.The patient recovered.The technical inspection of the dialog+ machine did not show a malfunction.It operated as intended.During this inspection, the event list of the dialog+ machine was also checked and an alarm indicating a low venous pressure was seen about 1 hour 15 minutes into therapy.This alarm indicates that the venous needle dislodgement occurred at that time.The data record provided is from 2022-05-03, one day after the occurrence of the described event.In this trend no "red" is detected at the red detector rdv of the sad indicating that there was no blood in the extracorporeal circuit.This is obviously the data record of a mock therapy.The data record shows the alarms "venous pressure - upper limit", "venous pressure - lower limit - check access", "venous pressure lower limit (sup)".Following each alarm, the dialog+ machine operated as intended and switched into patient-safe mode with blood pump stop.The received pictures show the screen of the dialog+ machine with the event list of a therapy performed on 2022-05-03, the date of occurrence of the described event.The event list shows that between 1:13 [h:mm] and 1:15 [h:mm] the alarms "venous pressure lower limit (sup)", "venous pressure - lower limit - check access" and "blood pump is stationary (sup)" were triggered.This is probably the time when the needle dislodgement occurred.Following the venous pressure alarm, the dialog+ machine switches into patient-safe mode.The alarm "blood pump is stationary (sup)" shoes that the blood pump had stopped at that time.Without the possibility to investigate the data record (trend) of the described event, no further information can be obtained.The evaluation of the service report shows that the dialog+ machine complained about operated as intended without a malfunction.In summary, the investigation of the trend data of the mock therapy, the pictures of the event list and the service report show that the dialog+ machine operated as intended and did not malfunction.Furthermore, it showed that the dialog+ machine triggered a venous pressure alarm and that the blood pump stopped in the therapy from which the event list was provided.The pressure monitoring system of a dialysis machine can detect venous needle dislodgement only if the venous pressure drops below the lower venous pressure limit.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).Therefore, the instructions for use of the dialog+ dialysis machine warns the user 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 a malfunction or product deviation of the dialog+ dialysis machine complained about, no further actions will be taken.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).It was reported that the venous needle dislodged during a therapy with a dialog+ dialysis machine.The venous needle either slipped out or was pulled accidently by the patient.According to the information received by the facility, the dialysis machine did not alarm, and the blood pump did not stop.After the venous needle dislodgement, the therapy was not resumed and the patient involved in the incident was sent to the emergency room for treatment after the event, required a blood transfusion.The patient recovered.The technical inspection of the dialog+ machine did not show a malfunction.It operated as intended.During this inspection, the event list of the dialog+ machine was also checked and an alarm indicating a low venous pressure was seen about 1 hour 15 minutes into therapy.This alarm indicates that the venous needle dislodgement occurred at that time.The data record provided is from 2022-05-03, one day after the occurrence of the described event.In this trend no "red" is detected at the red detector rdv of the sad indicating that there was no blood in the extracorporeal circuit.This is obviously the data record of a mock therapy.The data record shows the alarms "venous pressure - upper limit", "venous pressure - lower limit - check access", "venous pressure lower limit (sup)".Following each alarm, the dialog+ machine operated as intended and switched into patient-safe mode with blood pump stop.The received pictures show the screen of the dialog+ machine with the event list of a therapy performed on 2022-05-03, the date of occurrence of the described event.The event list shows that between 1:13 [h:mm] and 1:15 [h:mm] the alarms "venous pressure lower limit (sup)", "venous pressure - lower limit - check access" and "blood pump is stationary (sup)" were triggered.This is probably the time when the needle dislodgement occurred.Following the venous pressure alarm, the dialog+ machine switches into patient-safe mode.The alarm "blood pump is stationary (sup)" shoes that the blood pump had stopped at that time.Without the possibility to investigate the data record (trend) of the described event, no further information can be obtained.The evaluation of the service report shows that the dialog+ machine complained about operated as intended without a malfunction.In summary, the investigation of the trend data of the mock therapy, the pictures of the event list and the service report show that the dialog+ machine operated as intended and did not malfunction.Furthermore, it showed that the dialog+ machine triggered a venous pressure alarm and that the blood pump stopped in the therapy from which the event list was provided.The pressure monitoring system of a dialysis machine can detect venous needle dislodgement only if the venous pressure drops below the lower venous pressure limit.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).Therefore, the instructions for use of the dialog+ dialysis machine warns the user 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 a malfunction or product deviation of the dialog+ dialysis machine complained about, no further actions will be taken.

• Brand Name: DIALOG®
• Type of Device: HIGH PERMEABILIT
• Manufacturer (Section D): B. BRAUN AVITUM AG; schwarzenberger weg 73-79; melsungen, 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN AVITUM AG; schwarzenberger weg 73-79; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 14565054
• MDR Text Key: 300658716
• Report Number: 3002879653-2022-00019
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 04046963686345
• UDI-Public: (01)04046963686345
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 710200L
• Device Catalogue Number: 710200L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/22/2013
• 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