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); Hypovolemic Shock (1917)

Event Date 10/15/2021

Event Type  Injury  

Event Description

As reported by user facility: the venous line separated during treatment.Blood loss occurred and blood had to be given to the patient.Cpr also had to be performed.The machine did trigger the venous low pressure alarm.Per the customer's protocol, the machine was requested to be evaluated for malfunction.The evaluation of the technical data is ongoing.

• 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: 12737579
• MDR Text Key: 279575262
• Report Number: 2521402-2021-00074
• 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: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2021
• 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: 11/02/2021
• Device Age: 13 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention