MAUDE Adverse Event Report: B.BRAUN AVITUM AG DIALOG+®; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 710200K

Device Problems No Display/Image (1183); Loss of Power (1475)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/08/2018

Event Type  malfunction  

Event Description

During dialysis treatment b braun machine shut down.Screen went black.No power.Machine was plugged into red outlet.Wro was also plugged in and did not lose power.No other power down or loss of power in room except for b braun machine.From biomed: the unit in question was run for a 4 hr run and a citric/thermal yesterday (5 hrs total on time), then a full pm was performed today.There was nothing found during pm or the repair check that would bear on this issue or cause the unit to shut down.Unit was powered on from 7:30am till 4:30pm while pm, qa, and finally decalc/thermal were performed today (9 more hrs total on time).Most likely cause would be hospital power related (momentary sag in line voltage) but cannot substantiate as boiler operator couldn't provide any possible cause such as generator testing and there were no notes of any power issues left by maintenance either.

• Brand Name: DIALOG+®
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): B.BRAUN AVITUM AG; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 8284866
• MDR Text Key: 134337309
• Report Number: 8284866
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 710200K
• Device Catalogue Number: 710200K
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/14/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/29/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20075 DA