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

Catalog Number 710500L

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

Patient Problems Hemorrhage/Bleeding (1888); Hypovolemic Shock (1917)

Event Date 10/15/2021

Event Type  Injury  

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Event Description

As reported by user facility: the venous line separated during treatment.Blood loss occurred and blood had to be given to the patient.Cpr also had to be performed.The machine did trigger the venous low pressure alarm.Per the customer's protocol, the machine was requested to be evaluated for malfunction.The evaluation of the technical data is ongoing.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).The evaluation of the trend data record showed that about 38 minutes after the therapy start the venous pressure pv dropped suddenly below the lower pressure limit.The dialog+ machine triggered the alarms "venous pressure - lower limit - check access" and "venous pressure lower limit (sup)" and switched into patient-safe mode where blood pump stopped and the venous tubing clamp sakv closed.It is plausible that this drop in the venous pressure was caused by the described venous needle disconnection.The estimated blood loss between the pressure drop and the blood pump stop was 30 ml.The alarm was acknowledged 19 seconds after it was triggered.After the alarm was acknowledged, the therapy was continued for another 6 minutes with a venous pressure of about 55 mmhg (175 mmhg before the alarm) until the alarms "sad - air!" and "sad (sup)" were triggered.Following these alarms, the dialog+ machine switched into patient-safe mode.The blood pump had stopped and remained so until the end of the trend data recording.Assuming that the venous patient access was not relocated and tightened after the venous pressure alarm, the resulting blood loss can be estimated to be about 1600 ml at the blood flow rate of 300 ml/min.About 1:16 [h:mm] after the therapy start, the operator switched to reinfusion mode, but the trend data record shows that the blood pump was not restarted, meaning that the blood in the extracorporeal circuit was not reinfused to the patient.About 46 minutes after the therapy start the blood pressure measurement of the patient by the dialysis machine showed a blood pressure of 119/48 mmhg, pulse rate 214.The blood pressure at the start of therapy was 118/79 mmhg, pulse rate 65.The evaluation of the trend data record does not show any malfunction of the dialog+ machine.During the technical inspection, the technician recalibrated the arterial and the venous pressure.The mock therapy was performed without any failures and the dialog+ machine operated as intended.In the trend data record it can be seen that the zero-point of the arterial and the venous pressure was within the specified range of ± 10 mmhg during the therapy described above.Furthermore, both sensors measured plausible values and the machine triggered arterial and venous pressure alarms as intended.The venous needle dislodgement in the current case was detected and alarmed by the dialog+ dialysis machine, but dependent on the venous pressure drop and the alarm limits set, the pressure monitoring system of the dialog+ machine as dialysis machines in general, might not reliably detect a disconnection or dislodgement of the venous patient access.Therefore, special care must be taken regarding a venous needle dislodgement and thus, the instructions for use of the dialog+ dialysis machine shows the following warning: risk to patient due to blood loss if cannulas get disconnected or dislodged! standard monitoring function of the dialysis machine cannot ensure detection if the cannulas get disconnected or dislodged.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 be set to greater than or equal to 20 mmhg in tsm (technical service mode).The investigation of the actual case did not show a product deviation or malfunction.Furthermore, the potential risk and the respective measures regarding a dislodgment of the venous access are addressed in the instructions for use of the dialog+ dialysis machine.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: DIALOG+®
• Type of Device: DIALYZER, HIGH PERMEABILIT
• 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: jonathan severino ; 824 12th avenue; bethlehem, PA 18018-0027 ; 4847197287
• MDR Report Key: 12737576
• MDR Text Key: 279576567
• Report Number: 3002879653-2021-00074
• Device Sequence Number: 1
• Product Code: KDI
• 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,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 710500L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2008
• 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): Required Intervention; Other