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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX F250NRE DIALYZER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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OGDEN MANUFACTURING PLANT OPTIFLUX F250NRE DIALYZER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 0500325E
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/02/2020
Event Type  malfunction  
Manufacturer Narrative
Plant investigation: the plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.  .
 
Event Description
A user facility biomedical technician (biomed) reported that a dialyzer blood leak occurred at the beginning of a patient¿s hemodialysis (hd) treatment. The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm. Blood leak test strips were used and tested positive for the presence of blood. The patient¿s estimated blood loss (ebl) was approximately 300 ml. The patient was restarted on a new machine and treatment completed successfully. Additional information was requested, however, to date a response has not been received. It was not stated in the initial report that the patient experienced any serious injury, adverse event, or required any medical intervention as a result of the reported issue. The complaint device was reported to be available to be returned to the manufacturer for evaluation.
 
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Brand NameOPTIFLUX F250NRE DIALYZER
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
OGDEN MANUFACTURING PLANT
director, site quality
475 west 13th street
ogden UT 84404
Manufacturer (Section G)
OGDEN MANUFACTURING PLANT
director, site quality
475 west 13th street
ogden UT 84404
Manufacturer Contact
matthew amaral
920 winter st
waltham, MA 02451
7816999758
MDR Report Key11000357
MDR Text Key221539353
Report Number1713747-2020-00514
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861100170
UDI-Public00840861100170
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082414
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup,Followup
Report Date 01/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0500325E
Device Catalogue Number0500325E
Device Lot Number20JU04016
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received01/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/26/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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