MAUDE Adverse Event Report: B. BRAUN MEDICAL INC DIALOG+ DIALYZER, HIGH PERMEABILIT

Catalog Number 710500L

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

Patient Problem Insufficient Information (4580)

Event Date 04/06/2021

Event Type  Death  

Event Description

As reported by user facility: a patient had a cardio pulmonary incident during treatment and was taken to the emergency room and expired. The facility further reported that a sample of the dialysis fluid was taken. The potassium concentration appeared to be high. A new sample was sent for re-testing. The facility mixes the acid concentrate for the dialysis fluid on site.

• Brand Name: DIALOG+
• Type of Device: DIALYZER, HIGH PERMEABILIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC; schwarzenberger weg 73-79; melsungen, d-34212 ; GM
• MDR Report Key: 11679697
• Report Number: 2521402-2021-00015
• 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: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 710500L
• 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: 04/16/2021
• Distributor Facility Aware Date: 04/12/2021
• Device Age: 10 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/12/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

• Patient Outcome(s): Death