MAUDE Adverse Event Report: GAMBRO PRISMAFLEX CRRT

Model Number P/N 107493

Device Problems No Display/Image (1183); Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2016

Event Type  malfunction  

Event Description

It was reported that the crrt machine screen went blank and quit working while in use.Machine swapped out.It was reported there was no change in pt condition.

• Brand Name: PRISMAFLEX CRRT
• Type of Device: PRISMAFLEX CRRT
• Manufacturer (Section D): GAMBRO
• MDR Report Key: 5913326
• MDR Text Key: 53607827
• Report Number: MW5064411
• Device Sequence Number: 1
• Product Code: KDI
• 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: 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P/N 107493
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1