FRESENIUS HEMODIALYZER F8 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-03-15 for FRESENIUS HEMODIALYZER F8 NA manufactured by Fresenius Medical Care.

Event Text Entries

[310412] Pt experienced chills, vomiting and hypotension during hemodialysis therapy. Therapy was provided with an 11th-use hemodialyzer.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 518739
• MDR Report Key: 518739
• Date Received: 2004-03-15
• Date of Report: 2003-12-31
• Date of Event: 2003-12-03
• Date Facility Aware: 2003-12-03
• Report Date: 2003-12-31
• Date Reported to Mfgr: 2003-12-31
• Date Added to Maude: 2004-04-05
• 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: 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 Sequence Number: 1

• Brand Name: FRESENIUS HEMODIALYZER
• Generic Name: HEMODIALYZER
• Product Code: FKP
• Date Received: 2004-03-15
• Model Number: F8
• Catalog Number: NA
• Lot Number: UNK
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 507769
• 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: 2004-03-15
• Model Number: RS8330
• Catalog Number: NA
• Lot Number: UNK
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 2
• Device Event Key: 521357
• Manufacturer: MINNTECH CORP.
• Manufacturer Address: 14605 28TH AVE NORTH MINNEAPOLIS MN 55447 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2004-03-15