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

Catalog Number 710500L

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

Patient Problems Hemorrhage/Bleeding (1888); Hypovolemia (2243)

Event Date 10/08/2021

Event Type  Death  

Event Description

As reported by user facility: a patient passed away while on the machine.Per the nurses, the venous catheter came partially out but not all the way.They believe this may have happened when the patient pulled his arm under the blanket but it's not known for sure.The patient's arm was under a blanket and blood was coming out around the venous catheter.The arterial catheter was intact.Nurses said no low pressure venous alarm went off.The nurse checked on the patient and he wasn't responsive.The nurse pulled back the blanket and saw a big pile of blood and then the alarm went off.This occurred about three (3) plus hours into the treatment.

• 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: 12689881
• MDR Text Key: 278154067
• Report Number: 2521402-2021-00070
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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: 10/25/2021
• Distributor Facility Aware Date: 10/08/2021
• Device Age: 15 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/08/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death