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

Model Number 710200L

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

Patient Problem Death (1802)

Event Date 05/30/2020

Event Type  Death  

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).The investigation into this reported event is ongoing.A b.Braun technician completed a technical safety check on the machine per the service manual checklist.A self-test was run and a mock therapy was performed, both with passing results.The machine was disinfected and released for use.A follow-up report will be submitted when the results of the investigation are available.

Event Description

As reported by user facility: patient complained of shortness of breath (sob) during treatment and was taken off treatment early.Patient's oxygen saturation level dropped below 88%.Once the blood was returned the patient coded and passed away.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).A b.Braun technician completed a technical safety check on the machine per the service manual checklist.A self-test was run and a mock therapy was performed, both with passing results.The machine was disinfected and released for use.The evaluation of the data record of the dialog+ machine shows that the therapy ran for 1 hr 14 minutes without any issue.Then, the alarms "abpm: sys press.Is too low" and "abpm: dia press.Is too low" were triggered because the patient's blood pressure had dropped to 49:11 mmhg (pulse 80 bpm).The operator acknowledged the alarms and activated minimal ultrafiltration.This was obviously the time when the patient developed the shortness of breath.Seven minutes later the blood pressure was 133:49 mmhg (pulse 80 bpm).The operator deactivated the minimal ultrafiltration and activated it again shortly thereafter.The alarm "abpm: dia press.Is too low" was triggered again because the patient's blood pressure was 174:29 mmhg (pulse 93 bpm).Finally, the blood was returned to the patient 1 hr 30 minutes after therapy start.The evaluation of the data record of the dialog+ machine does not show a malfunction.The dialysis machine operated as intended.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
• MDR Report Key: 10137246
• MDR Text Key: 194604923
• Report Number: 3002879653-2020-00004
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 04046963686345
• UDI-Public: (01)04046963686345
• Combination Product (y/n): N
• PMA/PMN Number: K083460
• 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: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 710200L
• Device Catalogue Number: 710200L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR