AN-69 DIALYZER FIL-20

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 1999-04-23 for AN-69 DIALYZER FIL-20 manufactured by Gambro Healthcare.

Event Text Entries

[130243] External blood leak at cap during treatment. No injury or intervention.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 8010182-1999-00011
• MDR Report Key: 220661
• Report Source: 06,07
• Date Received: 1999-04-23
• Date of Report: 1999-04-23
• Date of Event: 1999-03-24
• Date Mfgr Received: 1999-03-24
• Date Added to Maude: 1999-04-28
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• 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: 0
• Single Use: 3
• Remedial Action: RL
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: AN-69 DIALYZER
• Generic Name: FILTRAL 20
• Product Code: FJG
• Date Received: 1999-04-23
• Model Number: FIL-20
• Catalog Number: FIL-20
• Lot Number: 98A1461
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 214005
• Manufacturer: GAMBRO HEALTHCARE
• Manufacturer Address: 1185 OAK ST LAKEWOOD CO 80215 US
• Baseline Brand Name: AN69 HOLLOW FIBER DIALYZER
• Baseline Generic Name: CAVH/D HEMOFILTRATION
• Baseline Model No: NA
• Baseline Catalog No: FIL-20
• Baseline ID: NA
• Baseline Device Family: HEMOFILTRATION
• Baseline Shelf Life Contained: Y
• Baseline Shelf Life [Months]: 36
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K901368
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1999-04-23