OPTIFLUX F18NRE DIALYZER FINISHED ASSY 0500308E

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-05-03 for OPTIFLUX F18NRE DIALYZER FINISHED ASSY 0500308E manufactured by Ogden Manufacturing Plant.

Event Text Entries

[107511385] The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
Patient Sequence No: 1, Text Type: N, H10


[107511386] A user facility reported that a dialyzer blood leak that occurred at the beginning of the patient? S hemodialysis (hd) treatment. The blood leak was noted as being an external blood leak. The leak was noted in the upper head of the dialyzer. The patient? S estimated blood loss (ebl) was approximately 10 ml. There was no defect or damage seen on the dialyzer. There was no patient injury, adverse events, or medical intervention required as a result of this event. The patient was restarted on the same machine and treatment completed successfully with new supplies. The complaint device was discarded and is not available to be returned to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5


[123750319] Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation. A production records review was performed on the reported lot. An investigation of the device history records (dhr) was conducted by the manufacturer. There was no indication of product nonacceptance, deviation, non-conformance, rework, labeling or process control failure during the manufacturing process which could be associated with the reported event. The lot met all release criteria. A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device. Therefore, the complaint is not confirmed.
Patient Sequence No: 1, Text Type: N, H10


[123750320]
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1713747-2018-00131
MDR Report Key7483759
Report SourceUSER FACILITY
Date Received2018-05-03
Date of Report2018-07-17
Date of Event2018-04-06
Date Mfgr Received2018-07-16
Device Manufacturer Date2015-09-29
Date Added to Maude2018-05-03
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 FDA3
Event Location3
Manufacturer ContactTHOMAS C. JOHNSON
Manufacturer Street920 WINTER ST.
Manufacturer CityWALTHAM MA 02451
Manufacturer CountryUS
Manufacturer Postal02451
Manufacturer Phone7816999499
Manufacturer G1OGDEN MANUFACTURING PLANT
Manufacturer Street475 WEST 13TH STREET
Manufacturer CityOGDEN UT 84404
Manufacturer CountryUS
Manufacturer Postal Code84404
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOPTIFLUX F18NRE DIALYZER FINISHED ASSY
Generic NameDIALYZER, CAPILLARY, HOLLOW FIBER
Product CodeFJI
Date Received2018-05-03
Catalog Number0500308E
Lot Number15LU02006
Device Expiration Date2018-09-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeMO
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerOGDEN MANUFACTURING PLANT
Manufacturer Address475 WEST 13TH STREET OGDEN UT 84404 US 84404


Patients

Patient NumberTreatmentOutcomeDate
10 2018-05-03

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