Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 160NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OGDEN MANUFACTURING PLANT OPTIFLUX 160NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 0500316E
Device Problem Fluid/Blood Leak (1250)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/26/2021
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
It was reported to fresenius that an internal dialyzer blood leak occurred within the first ten minutes of a patient¿s hemodialysis (hd) treatment.Four minutes into the treatment, the machine alarmed multiple times with a ¿minor blood leak¿ alert.The patient was alert, oriented, and talking.The patient care technician (pct) went to retrieved blood test strips.Five minutes later, the machine alarmed ¿blood leak¿.At this point the treatment was stopped.Two blood test strips were used to test for the presence of blood, and they both tested positive.No damage was identified on the dialyzer.Fresenius bloodlines were being utilized for the treatment.The patient¿s blood was not returned; estimated blood loss (ebl) was reported to be 300 ml.The patient was provided an explanation of what had occurred, and they verbalized understanding.It was confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient completed their treatment after being re-setup with new supplies on a different machine.The dialyzer was reported to be available for a manufacturer evaluation.
 
Event Description
It was reported to fresenius that an internal dialyzer blood leak occurred within the first ten minutes of a patient¿s hemodialysis (hd) treatment.Four minutes into the treatment, the machine alarmed multiple times with a ¿minor blood leak¿ alert.The patient was alert, oriented, and talking.The patient care technician (pct) went to retrieved blood test strips.Five minutes later, the machine alarmed ¿blood leak¿.At this point the treatment was stopped.Two blood test strips were used to test for the presence of blood, and they both tested positive.No damage was identified on the dialyzer.Fresenius bloodlines were being utilized for the treatment.The patient¿s blood was not returned; estimated blood loss (ebl) was reported to be 300 ml.The patient was provided an explanation of what had occurred, and they verbalized understanding.It was confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient completed their treatment after being re-setup with new supplies on a different machine.The dialyzer was reported to be available for a manufacturer evaluation.
 
Manufacturer Narrative
Additional information: h3 plant investigation: although a sample was reported to be available for manufacturer evaluation, as of 03/05/2021 no sample has been received.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.Should the sample be returned at a later date, a supplemental report will be submitted capturing the updated investigation results.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
OPTIFLUX 160NRE DIALYZER FINISHED ASSY.
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
OGDEN MANUFACTURING PLANT
director, site quality
475 west 13th street
ogden UT 84404
MDR Report Key11303025
MDR Text Key231716383
Report Number1713747-2021-00039
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861100149
UDI-Public00840861100149
Combination Product (y/n)N
PMA/PMN Number
K002761
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 03/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2023
Device Model Number0500316E
Device Catalogue Number0500316E
Device Lot Number20KU06028
Was Device Available for Evaluation? Yes
Device AgeMO
Date Manufacturer Received03/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
FRESENIUS 2008T MACHINE.; FRESENIUS 2008T MACHINE.; FRESENIUS BLOODLINES.; FRESENIUS BLOODLINES.
Patient Age45 YR
Patient Weight76
-
-