MAUDE Adverse Event Report: GAMBRO BY BAXTER DIALYZSER HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM; PRISMAFLEX MACHINE

Model Number 007-00254

Device Problem Loss of Power (1475)

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

Event Date 03/06/2018

Event Type  malfunction  

Event Description

Crrt machine had power failure, turned off by itself during crrt cycle.

• Brand Name: DIALYZSER HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Type of Device: PRISMAFLEX MACHINE
• Manufacturer (Section D): GAMBRO BY BAXTER
• MDR Report Key: 7323212
• MDR Text Key: 102074899
• Report Number: MW5075752
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 007-00254
• Device Lot Number: 10560
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR