PRISMAFLEX *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-11-08 for PRISMAFLEX * manufactured by Gambro Renal Products, Inc..

Event Text Entries

[18488896] Continuous renal replacement therapy (crrt) machine in use when filter clotted off. A new system initiated, and "air in line" alarm received without a way to clear. New crrt machine attained, when turned on was "stuck" in the reprime screen. Device turned off and then back on; same screen appeared. This step repeated with same result. Dialysis called, and was instructed to turn off again and restart. The screen did not change. Dialysis notified and told to get a new machine. Attained new machine, and started priming. During prime test machine failed at 2nd bar multiple times. Dialysis called and new machine delivered pre-primed. Previous two machines placed in dirty utility room with signs placed on the machines with descriptors of problems. Devices transported to biomed a few days later.
Patient Sequence No: 1, Text Type: D, B5

[18582127] Continuous renal replacement therapy (crrt) machine in use when filter clotted off. A new system initiated, and "air in line" alarm received without a way to clear. New crrt machine attained, when turned on was "stuck" in the reprime screen. Device turned off and then back on; same screen appeared. This step repeated with same result. Dialysis called, and was instructed to turn off again and restart. The screen did not change. Dialysis notified and told to get a new machine. Attained new machine, and started priming. During prime test machine failed at 2nd bar multiple times. Dialysis called and new machine delivered pre-primed. Previous two machines placed in dirty utility room with signs placed on the machines with descriptors of problems. Devices transported to biomed a few days later.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1526386
• MDR Report Key: 1526386
• Date Received: 2009-11-08
• Date of Report: 2009-11-08
• Date of Event: 2009-09-18
• Report Date: 2009-11-08
• Date Reported to FDA: 2009-11-08
• Date Added to Maude: 2009-11-13
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: PRISMAFLEX
• Generic Name: HEMODIALYSIS, CONTINUOUS RENAL REPLACEMENT THERAPY
• Product Code: MQS
• Date Received: 2009-11-08
• Model Number: PRISMAFLEX
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: NURSE
• Device Availability: Y
• Device Age: 6 MO
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: GAMBRO RENAL PRODUCTS, INC.
• Manufacturer Address: VICE PRESIDENT REGULATORY AFFA 14143 DENVER WEST PARKWAY, SUI LAKEWOOD CO 80401 US 80401

Device Sequence Number: 2

• Brand Name: PRISMAFLEX
• Generic Name: HEMODIALYSIS, CONTINUOUS RENAL REPLACEMENT THERAPY
• Product Code: MQS
• Date Received: 2009-11-08
• Model Number: PRISMAFLEX
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: 6 MO
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: GAMBRO RENAL PRODUCTS, INC.
• Manufacturer Address: 14143 DENVER WEST PARKWAY, SUI LAKEWOOD CO 80401 US 80401

Patients

Patient Number	Treatment	Outcome	Date
1	0		2009-11-08