FILTRAL 20 FIL-20

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2000-03-08 for FILTRAL 20 FIL-20 manufactured by Hospal Industrie.

Event Text Entries

[22181286] Approximately 90 seconds into the treatment, the pt complained of shortness of breath. The pt was noted to be diaphoretic and anxious, with a decrease in blood pressure and an increase in pulse. The pt was switched to a polyflux 17s dialyzer. The pt required oxygen and underwent testing; lab analysis was positive for allergic reaction.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8010182-2000-00002
MDR Report Key267760
Report Source05,06
Date Received2000-03-08
Date of Report2000-02-07
Date of Event2000-02-04
Date Mfgr Received2000-02-07
Date Added to Maude2000-03-09
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 Street10810 W. COLLINS AVE
Manufacturer CityLAKEWOOD CO 80215
Manufacturer CountryUS
Manufacturer Postal80215
Manufacturer Phone3032314186
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 NameFILTRAL 20
Generic NameDIALYZER
Product CodeFJG
Date Received2000-03-08
Model NumberNA
Catalog NumberFIL-20
Lot Number98E1561
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key259208
ManufacturerHOSPAL INDUSTRIE
Manufacturer Address7, AVE LIONEL TERRAY MEYZIEU FR 69330
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 2000-03-08

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