MAUDE Adverse Event Report: B. BRAUN AVITUM AG DAILOG DAILYSIS MACHINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number SW 9.1X

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Death (1802)

Event Date 08/08/2020

Event Type  Death  

Event Description

Citric acid used in place of bicarbonate. B braun dialog dialysis machine sw 9. 1x does not have built in ph meter and allowed user to continue administering dialysis without checking ph. Fda safety report id# (b)(4).

• Brand Name: DAILOG DAILYSIS MACHINE
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): B. BRAUN AVITUM AG
• MDR Report Key: 10448034
• MDR Text Key: 204352725
• Report Number: MW5096218
• 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: Voluntary

Reporter Occupation

• Type of Report: Initial
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: Yes

Device Operator

• Device Model Number: SW 9.1X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 08/24/2020 Patient Sequence Number: 1