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 report with the FDA on 1999-10-10 for AN-69 FIL-20 manufactured by Hospal Industrie.

Event Text Entries

[17106663] Pt #3. Blood leak to atmosphere from the dialyzer header approx 10 mins into the treatment. Blood loss was estimated at 5-10 cc. There was no pt injury or medical intervention. No evidence of cracking was found during prime.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8010182-1999-00023
MDR Report Key244386
Report Source06
Date Received1999-10-10
Date of Report1999-09-10
Date of Event1999-09-08
Date Mfgr Received1999-09-10
Date Added to Maude1999-10-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactROBBIN PROCOPIO
Manufacturer Street1185 OAK ST
Manufacturer CityLAKEWOOD CO 80215
Manufacturer CountryUS
Manufacturer Postal80215
Manufacturer Phone302314186
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Remedial ActionOT
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameAN-69
Generic NameDIALYZER
Product CodeFJG
Date Received1999-10-10
Model NumberFIL-20
Catalog NumberFIL-20
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key236764
ManufacturerHOSPAL INDUSTRIE
Manufacturer Address7, AV. LIONEL TERRAY BP 126 MEYZIEU CEDEX FR F-69883
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 1999-10-10

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