* PRISMAFLEX N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-09-27 for * PRISMAFLEX N/A manufactured by Gambro Renal Products, Inc.

Event Text Entries

[1235851] There was a power outage, and thirty minutes later there was another power outage with the patient monitors. The patient's oscillator and crrt (continuous renal replacement therapy) machine got turned off. During the initial outage the crrt machine went down and the circuit clotted, and during the second outage the oscillator took time to restart, which led to the patient's oxygen desaturation. The patient needed to be disconnected from the circuit and bagged. These were major avoidable patient morbidities in a critically ill patient that occurred primarily due to the scheduled generator check. This system of checking the generator by turning off critical support to the patient needs to be addressed and changed before a mortality occurs due to the process.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1490691
• MDR Report Key: 1490691
• Date Received: 2009-09-27
• Date of Report: 2009-09-25
• Date of Event: 2009-08-13
• Report Date: 2009-09-25
• Date Reported to FDA: 2009-09-27
• Date Added to Maude: 2009-10-05
• 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
• 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: *
• Generic Name: HEMODIALYSIS, CRRT
• Product Code: MQS
• Date Received: 2009-09-27
• Model Number: PRISMAFLEX
• Catalog Number: N/A
• Lot Number: N/A
• ID Number: *
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: GAMBRO RENAL PRODUCTS, INC
• Manufacturer Address: 10810 WEST COLLINS AVENUE LAKEWOOD CO 80215 US 80215

Device Sequence Number: 2

• Brand Name: *
• Generic Name: VENTILATOR, HFOV
• Product Code: BZO
• Date Received: 2009-09-27
• Model Number: 3100
• Catalog Number: N/A
• Lot Number: N/A
• ID Number: *
• Device Availability: Y
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: CAREFUSION
• Manufacturer Address: 3750 TORREY VIEW COURT SAN DIEGO CA 92130 US 92130

Patients

Patient Number	Treatment	Outcome	Date
1	0		2009-09-27