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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

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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 Problems Fire (1245); Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/17/2021
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 reported that an internal dialyzer blood leak occurred during a patients hemodialysis (hd) treatment. Upon follow up with a nurse at the user facility, it was reported that the blood leak occurred immediately after initiation of the hemodialysis treatment the blood leak was visually observed in the top of venous side of the dialyzer. The unspecified fresenius hemodialysis machine alarmed appropriately with a blood leak alert. Blood leak test strips were used and tested positive for the presence of blood. Fresenius bloodlines were used for the treatment. There was no reported damage identified on the dialyzer. After the machine alarmed, treatment was halted; it was unknown if the patients blood was returned. There were no reported blood loss. 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 was able to complete treatment after being set up with new supplies on the same machine. It was unspecified if the dialyzer was available to be returned for evaluation. Photos were provided for evaluation.
 
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Brand NameOPTIFLUX 160NRE DIALYZER FINISHED ASSY.
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 Key12268259
MDR Text Key264781845
Report Number1713747-2021-00248
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K002761
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 08/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number0500316E
Device Catalogue Number0500316E
Device Lot Number21DU01013
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received08/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/20/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/03/2021 Patient Sequence Number: 1
Treatment
FRESENIUS BLOODLINES; FRESENIUS HEMODIALYSIS MACHINE
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