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  

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 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
• 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: 13741319
• MDR Text Key: 287100393
• Report Number: 3002879653-2022-00017
• 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: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• 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

• Device Catalogue Number: 710500K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 03/11/2022 Patient Sequence Number: 1