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); Hypovolemia (2243)

Event Date 10/08/2021

Event Type  Death  

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: a patient passed away while on the machine.Per the nurses, the venous catheter came partially out but not all the way.They believe this may have happened when the patient pulled his arm under the blanket but it's not known for sure.The patient's arm was under a blanket and blood was coming out around the venous catheter.The arterial catheter was intact.Nurses said no low pressure venous alarm went off.The nurse checked on the patient and he wasn't responsive.The nurse pulled back the blanket and saw a big pile of blood and then the alarm went off.This occurred about three (3) plus hours into the treatment.

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 2:29 [h:mm] after therapy start, the venous pressure decreased from about 190 mmhg to about 140 mmhg.Since the lower venous pressure limit was 138 mmhg, no alarm was triggered.This might have been the time when the venous access dislocated.At 2:31 [h:mm] the alarm "arterial pressure - lower limit" was triggered.The blood pump stopped and the dialysis machine switched into patient-safe mode.As a follow-up alarm due to the stop of the blood pump, the alarm "venous pressure - lower limit - check access" was triggered.The alarms were acknowledged by the operator.Twenty-three (23) minutes later the alarm "venous pressure - upper limit" was triggered and also acknowledged by the operator.After another eight (8) minutes the alarm "venous pressure - lower limit - check access" was triggered and acknowledged by the operator.This was likely the time the nurse detected the dislocation of the venous access.Until the trend data record ended abruptly, about 30 minutes later, numerous air and pressure alarms were triggered.The evaluation of the trend data record does not show any malfunction of the dialog+ dialysis machine.It operated as intended.The technical inspection of the dialog+ machine showed that the blood pressure measuring (abpm) module was inoperative, otherwise the dialog+ machine operated as intended.The therapy in question was performed without using the abpm module.Thus it did not have any influence on the situation described above.Furthermore, even if it would have been used, it would not have had an influence.As outlined in iec/tr 62653 (guideline for safe operation of medical equipment used for haemodialysis treatments), the venous pressure monitor of a dialysis machine may not reliably detect leaks, blood tubing separation from the blood access device, or needle dislodgement.Little or no pressure change may occur depending on the circumstance.It is unlikely but possible for a leak to occur, the blood tubing to separate, or access needle to dislodge without venous pressure alarm.For that reason, the patient's safety is only ensured by careful monitoring by the operator.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, 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).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: 12689865
• MDR Text Key: 278153901
• Report Number: 3002879653-2021-00070
• 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: 12/09/2021

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 Catalogue Number: 710500L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2021
• Initial Date FDA Received: 10/25/2021
• Supplement Dates Manufacturer Received: 10/08/2021
• Supplement Dates FDA Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2006
• 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
• Patient Sex: Male