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

Catalog Number 710500K

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

Patient Problem Cardiac Arrest (1762)

Event Date 03/02/2022

Event Type  Death  

Event Description

As reported by user facility: a patient had a code episode and passed away.The machine was removed from service.Pyrogen and bacteriology samples were collected and tested with negative results.The machine was run in simulated treatment mode twice.The dialysate temperature calibration had drifted (34.3°c external meter, machine indicated 37.0°c).The conductivity calibration had also drifted (14.331ms/cm external meter, machine endlf indicated 13.7ms/cm; endlf_s indicated 14.1ms/cm).The ph was 7.5.An electrical safety check was run and no problem was found.There was no level of patient electrical leakage found.

• 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: 13741266
• MDR Text Key: 287100136
• Report Number: 2521402-2022-00017
• 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: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 710500K
• Device Lot Number: 30813
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/11/2022
• Distributor Facility Aware Date: 03/07/2022
• Device Age: 14 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/09/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death