PHOENIX 6023006700

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-02-06 for PHOENIX 6023006700 manufactured by Gambro Dasco.

Event Text Entries

[829473] Gambro rec'd a complaint on january 8, 2008 from a facility who reported that a phoenix machine was leaking. It was unk when the leak occurred. There was no pt injury or medical intervention warranted in this event. No evidence that a tubing disconnection related alarm occurred. A gambro tech inspected the machine and found that it was leaking at the outlet of po. He reconnected tubing at the po. He performed a rinse cycle, and a t1 test. He verified no other leaks from the machine and performed disinfection without any problem.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2087532-2008-00011
• MDR Report Key: 1012274
• Date Received: 2008-02-06
• Date of Report: 2008-01-08
• Date of Event: 2008-01-01
• Date Facility Aware: 2008-01-08
• Report Date: 2008-01-08
• Date Reported to Mfgr: 2008-01-08
• Date Added to Maude: 2008-03-14
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• 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 Details

• Brand Name: PHOENIX
• Generic Name: HEMODIALYSIS EQUIPMENT
• Product Code: FID
• Date Received: 2008-02-06
• Model Number: PHOENIX
• Catalog Number: 6023006700
• Lot Number: NA
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 5 YR
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 979490
• Manufacturer: GAMBRO DASCO
• Manufacturer Address: VIA MODENESE, 66 MEDOLLA (MO) IT I-41036

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2008-02-06