AN-69 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 1998-12-23 for AN-69 FIL-20 manufactured by Gambro Healthcare.

Event Text Entries

[163785] External blood leak at the port of the filter where the blood tubing connects. No pt injury or invervention.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8010182-1998-00004
MDR Report Key203675
Report Source06,07
Date Received1998-12-23
Date of Report1998-12-23
Date Mfgr Received1998-11-27
Date Added to Maude1998-12-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use3
Remedial ActionRL
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameAN-69
Generic NameFILTRAL 20
Product CodeFJG
Date Received1998-12-23
Model NumberNA
Catalog NumberFIL-20
Lot Number98D0120B
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key197828
ManufacturerGAMBRO HEALTHCARE
Manufacturer Address1185 OAK ST LAKEWOOD CO 80215 US
Baseline Brand NameAN69 HOLLOW FIBER DIALYZER
Baseline Generic NameCAVH/D HEMOFILTRATION
Baseline Model NoNA
Baseline Catalog NoFIL-20
Baseline IDNA
Baseline Device FamilyHEMOFILTRATION
Baseline Shelf Life ContainedY
Baseline Shelf Life [Months]36
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK901368
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1998-12-23

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