OPTIFLUX OPTIFLUX 200A NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-07-02 for OPTIFLUX OPTIFLUX 200A NA manufactured by Fresenius Medical Care.

Event Text Entries

[292056] Pt experienced shaking chills at conclusion of hemodialysis therapy. Refused antibiotics and was sent home. Became febrile while at home. Received hemodialysis therapy 2 days later and was then hospitalized for treatment of infection. Subsequent investigation led to discovery of yeast organism beneath o-ring and in o-ring groove of reused dialyzer header cap.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 473386
• MDR Report Key: 473386
• Date Received: 2003-07-02
• Date of Report: 2003-06-10
• Date of Event: 2003-04-24
• Date Facility Aware: 2003-04-24
• Report Date: 2003-06-10
• Date Reported to Mfgr: 2003-06-11
• Date Added to Maude: 2003-07-25
• 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: OPTIFLUX
• Generic Name: HEMODIALYZER
• Product Code: KDI
• Date Received: 2003-07-02
• Model Number: OPTIFLUX 200A
• Catalog Number: NA
• Lot Number: 2PU118 (OPTIFLUX)
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 462231
• Manufacturer: FRESENIUS MEDICAL CARE
• Manufacturer Address: 95 HAYDEN AVE LEXINGTON MA 02420 US
• Baseline Brand Name: OPTIFLUX 200A DIALYZER FINISHED ASSY.
• Baseline Generic Name: HEMODIALYZER REPROCESSING DEVICE
• Baseline Model No: NA
• Baseline Catalog No: 0500320A
• Baseline ID: 0500320A

Device Sequence Number: 2

• Brand Name: RENATRON
• Generic Name: REPROCESSING DEVICE
• Product Code: LIF
• Date Received: 2003-07-02
• Model Number: R58330
• Catalog Number: NA
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 2
• Device Event Key: 462233
• Manufacturer: MINNTECH CORP
• Manufacturer Address: 14605 28TH AVE NORTH MINNEAPOLIS MN 55447 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Other	2003-07-02