FRESENIUS HEMODIALYZER RSB330 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-01-20 for FRESENIUS HEMODIALYZER RSB330 NA manufactured by Fresenius Medical Care.

Event Text Entries

[358570] Pt experienced chills, nausea and vomiting, hypotension and shortness of breath approx 70 minutes after initiating hemodialysis therapy. Therapy was provided with a 17th use hemodialyzer.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 507813
• MDR Report Key: 507813
• Date Received: 2004-01-20
• Date of Report: 2003-12-19
• Date of Event: 2003-11-25
• Date Facility Aware: 2003-11-25
• Report Date: 2003-12-19
• Date Reported to Mfgr: 2003-12-19
• Date Added to Maude: 2004-01-27
• 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: 3
• 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: FRESENIUS HEMODIALYZER
• Generic Name: HEMODIALYZER
• Product Code: FJI
• Date Received: 2004-01-20
• Model Number: RSB330
• Catalog Number: NA
• Lot Number: UNK
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 496760
• Manufacturer: FRESENIUS MEDICAL CARE
• Manufacturer Address: 95 HAYDEN AVE LEXINGTON MA 02420 US

Device Sequence Number: 2

• Brand Name: RENATRON
• Generic Name: REPROCESSING DEVICE
• Product Code: LIF
• Date Received: 2004-01-20
• Model Number: F80A
• Catalog Number: NA
• Lot Number: UNK
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 2
• Device Event Key: 496800
• Manufacturer: MINNTECH CORP
• Manufacturer Address: 14601 28TH AVE NORTH MINNEAPOLIS MN 55447 US
• Baseline Brand Name: FRESENIUS HEMOFLOW DIALYZER, HIGH FLUX
• Baseline Generic Name: HOLLOW FIBER DIALYZER
• Baseline Model No: F80A
• Baseline Catalog No: 0500154A
• Baseline ID: NA
• Baseline Device Family: HIGH FLUX DIALYZERS
• Baseline Shelf Life Contained: Y
• Baseline Shelf Life [Months]: 36
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K926006
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Other	2004-01-20