F80A DIALYZER FINISHED ASSY 0500154A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2014-03-06 for F80A DIALYZER FINISHED ASSY 0500154A manufactured by Ogden Manufacturing.

Event Text Entries

[4454592] A hemodialysis inpatient user facility has reported that during treatment, a blood leak occurred. The leak was visually observed from the head of the dialyzer and the machine alarmed. Estimated blood loss was 20cc's. Pt had no adverse effects and required no medical intervention. Sample has not been returned to the mfr.
Patient Sequence No: 1, Text Type: D, B5


[11819320] The plant investigation has not yet been completed. A f/u report will be filed upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1713747-2014-00094
MDR Report Key3837857
Report Source05,06,07
Date Received2014-03-06
Date of Report2014-02-04
Date of Event2014-01-31
Date Mfgr Received2014-02-04
Device Manufacturer Date2013-05-01
Date Added to Maude2014-06-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactJENNIFER NABUKENYA
Manufacturer Street920 WINTER ST.
Manufacturer CityWALTHAM MA 02451
Manufacturer CountryUS
Manufacturer Postal02451
Manufacturer Phone8006621237
Manufacturer G1OGDEN MANUFACTURING PLANT
Manufacturer Street475 WEST 13TH ST.
Manufacturer CityOGDEN UT 84404
Manufacturer CountryUS
Manufacturer Postal Code84404
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameF80A DIALYZER FINISHED ASSY
Product CodeMSE
Date Received2014-03-06
Catalog Number0500154A
Lot Number13EU03006
Device Expiration Date2016-05-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerOGDEN MANUFACTURING
Manufacturer AddressOGDEN UT US


Patients

Patient NumberTreatmentOutcomeDate
14008 2014-03-06

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