MAUDE Adverse Event Report: GAMBRO RENAL PRODUCTS, INC. PRISMAFLEX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 107493

Device Problems No Display/Image (1183); Failure to Power Up (1476); Unexpected Shutdown (4019)

Patient Problem Insufficient Information (4580)

Event Date 04/21/2021

Event Type  malfunction  

Event Description

Prisma was running normally and shut down without warning.Screen turned black and alarm beeping.Could not turn on again.Had to immediately disconnect the patient from the machine to prevent clotting of the lines.

• Brand Name: PRISMAFLEX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): GAMBRO RENAL PRODUCTS, INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 11831227
• MDR Text Key: 250841105
• Report Number: 11831227
• 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: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 107493
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/27/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/17/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17885 DA