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

Model Number 710200S

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

Patient Problem Loss of consciousness (2418)

Event Date 10/13/2020

Event Type  Injury  

Event Description

As reported by user facility: there was a patient that went unresponsive at the end of a therapy with a dialog+ dialysis machine.The patient came by wheelchair.The staff remarked how he normally walked in the clinic.The patient said that he had not felt very good after starting a new shingles medication.Toward the end of the treatment the patient went unresponsive, staff began cpr and the patient was transported to the emergency room by ambulance.

• 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: 10684401
• MDR Text Key: 211506689
• Report Number: 2521402-2020-00007
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 04046964285608
• UDI-Public: (01)04046964285608
• 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: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 710200S
• Device Catalogue Number: 710200S
• 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: 10/15/2020
• Distributor Facility Aware Date: 10/13/2020
• Device Age: 3 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening