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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 0500318E
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/18/2021
Event Type  malfunction  
Event Description
It was reported to fresenius that this patient with end stage renal disease (esrd) on hemodialysis (hd) for renal replacement therapy (rrt) was hospitalized (admission date not provided) due to liver failure, and experienced multiple blood leak alarms during hd therapy on (b)(6) 2021. Follow-up with the inpatient bio-medical technician (bmt) and clinical charge nurse (ccn) confirmed the patient was undergoing hd therapy on (b)(6) 2021, when approximately 5 minutes into treatment a blood leak alarm occurred (investigated in mfr 1713747-2021-00457). The patient¿s treatment was restarted on the same hd machine, when a blood leak alarm occurred. Again, a blood leak test strip confirmed the presence of blood in the dialysate. Additionally, it was reported the return dialysate was visibly ¿tinted¿ yellow. The treatment was terminated a second time, and the patient¿s blood could not be returned, which resulted in 250 ml of blood loss (500 ml total). A different hd machine was utilized to set-up for a third attempt to continue treatment. The cn confirmed the lot # was sequestered following the events and were not utilized with any other patient. Per the hospital nephrologist, it was suspected the patient¿s severely elevated bilirubin level ¿falsely tripped the blood leak alarm;¿ however, it cannot be explained why the blood leak strips were positive.
 
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.  .
 
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Brand NameOPTIFLUX 180NRE 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
jason busch
920 winter st
waltham, MA 02451
9043166958
MDR Report Key12975523
MDR Text Key284830271
Report Number1713747-2021-00458
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 Health Professional,User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0500318E
Device Catalogue Number0500318E
Device Lot Number21HU03008
Was Device Available for Evaluation? No
Device AgeMO
Date Manufacturer Received01/05/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/15/2021
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: 12/10/2021 Patient Sequence Number: 1
Treatment
FRESENIUS HEMODIALYSIS (HD) MACHINE; FRESENIUS HEMODIALYSIS (HD) MACHINE
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