FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR N/A 9400408

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-01-02 for FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR N/A 9400408 manufactured by Fresenius Hemocare Netherlands B.v..

Event Text Entries

[188834024] Patient underload.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3002807758-2019-00002
MDR Report Key9537791
Report SourceFOREIGN,USER FACILITY
Date Received2020-01-02
Date of Report2019-12-06
Date of Event2019-12-05
Date Facility Aware2019-12-06
Report Date2019-12-06
Date Reported to Mfgr2019-12-06
Date Mfgr Received2019-12-06
Device Manufacturer Date2018-05-20
Date Added to Maude2020-01-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. VICKI MCKEE
Manufacturer Street3 CORPORATE DRIVE
Manufacturer CityLAKE ZURICH IL 60047
Manufacturer CountryUS
Manufacturer Postal60047
Manufacturer Phone8475500157
Manufacturer G1FRESENIUS HEMOCARE NETHERLANDS B.V.
Manufacturer StreetRUNDE ZZ 41
Manufacturer CityEMMER-COMPASCUUM, NL-7881 H
Manufacturer CountryNL
Manufacturer Postal CodeNL-7881 HM
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFRESENIUS COM.TEC AUTOMATED CELL SEPARATOR
Generic NameCOM.TEC PL1 RED CELL / PLASMA EXCHANGE SET
Product CodeLKN
Date Received2020-01-02
Model NumberN/A
Catalog Number9400408
Lot NumberHET203
Device AvailabilityN
Device Age565 DA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerFRESENIUS HEMOCARE NETHERLANDS B.V.
Manufacturer AddressRUNDE ZZ 41 EMMER-COMPASCUUM, NL-7881 H NL NL-7881 HM


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-02

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