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

Catalog Number 710500KU

Device Problem Infusion or Flow Problem (2964)

Patient Problem Respiratory Distress (2045)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device involved was inspected onsite by a b.Braun service team member.A safety test was performed without any anomalies.All values were within tolerance.A 15 minute mock treatment was performed and the machine performed as expected without alarms.The trend data was reviewed and multiple venous alarms occurred throughout treatment, both high and low.If additional pertinent information becomes available a follow-up report will be filed.

Event Description

As reported by the user facility: it was believed to be a blood pump issue.The patient was not breathing and pulse palpable.The patient was reinfused and breathing resumed prior to starting cpr or any other intervention.A (b)(6) year old male with diagnosis of hypertensive chronic kidney disease.The patient became unresponsive and stopped breathing retained pulse, became alert after blood returned, oxygen given, and a few sternal rubs.The patient was sent to emergency room (er) and discharged with no changes to ekg.Possible vasovagal response was considered as the patient had three very forceful sneezes just prior to loosing consciousness.No other interventions required.

Manufacturer Narrative

This report has been identified as b.Braun avitum internal report # (b)(4).The device involved was inspected onsite by a b.Braun service team member.A safety test was performed without any anomalies.All values were within tolerance.A 15 minute mock treatment was performed and the machine performed as expected without alarms.The trend data was reviewed and multiple venous alarms occurred throughout treatment, both high and low.During the complete therapy, the dialog+ machine operated and reacted to the alarms as intended and neither the technical inspection on-site, nor the evaluation of the data records showed any malfunction.The dialog+ dialysis machine operated as intended and no further action will be taken.If additional pertinent information becomes available a follow-up report will be filed.Event description was corrected to the following: it was determined that bp meant blood pressure, not blood pump.

Event Description

As reported by the user facility: it was believed to be a blood pump issue.The patient was not breathing and pulse palpable.The patient was reinfused and breathing resumed prior to starting cpr or any other intervention.63 year old male with diagnosis of hypertensive chronic kidney disease.The patient became unresponsive and stopped breathing retained pulse, became alert after blood returned, oxygen given, and a few sternal rubs.The patient was sent to emergency room (er) and discharged with no changes to ekg.Possible vasovagal response was considered as the patient had three very forceful sneezes just prior to loosing consciousness.No other interventions required.Correction: it was determined that bp meant blood pressure, not blood pump.

• Brand Name: DIALOG+®
• Type of Device: HIGH PERMEABILIT
• Manufacturer (Section D): B. BRAUN AVITUM AG - MELSUNGEN; schwarzenberger weg 73-79; melsungen, D-342 12; GM D-34212
• MDR Report Key: 8667344
• MDR Text Key: 146972119
• Report Number: 3002879653-2019-00007
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 710500KU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR