MAUDE Adverse Event Report: FRESENIUS MEDICAL FRESENIUS DIAYSIS MACHINE

Model Number 2008T

Device Problems Component Falling (1105); Fracture (1260)

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

Event Date 01/16/2017

Event Type  malfunction  

Event Description

Dialysis 2008t machine fell over due to a caster breaking off its mounting. The machine was not being transported at the time of the incident. It was simply standing in a rinse cycle. The machine is only four years old. When examined, the caster is mounted directly into a threaded socket that is cast into the plastic chassis. These seems like an inherently weak design. Several of the supporting plastic mounts had fractures in them. The standard repair is to replace the entire chassis. This is very time consuming, but even more important someone standing next to the unit or a pt being treated could be harmed. Mfr was contacted, but offered no concern other than treating this as a normal failure and repair.

• Brand Name: FRESENIUS
• Type of Device: DIAYSIS MACHINE
• Manufacturer (Section D): FRESENIUS MEDICAL; concord CA 94520
• MDR Report Key: 6279317
• MDR Text Key: 65941421
• Report Number: MW5067478
• Device Sequence Number: 1
• Product Code: KDI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/20/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 2008T
• 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?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage