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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 Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/18/2021
Event Type  Injury  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.   clinical investigation: clinical investigation: a temporal relationship exists between hd therapy utilizing an optiflux 180nre dialyzer, and the serious adverse event of blood loss (approximately 250 ml), as the patient was actively undergoing hd therapy when the events occurred. Per the ccn and bmt, a blood leak test strip confirmed the presence of blood within the dialysate line and was visibly tinted yellow. Although the hospital nephrologist suspected the patient¿s elevated bilirubin level falsely tripped the blood leak alarm, it does not explain why the blood leak test strip was positive. Based on the totality of the information available, the optiflux 180nre dialyzer cannot be excluded from having a possible causal/contributory role in the patient¿s blood loss event. Statements from the bmt and ccn indicate a fresenius device(s) and/or product(s) defect, deficiency and/or malfunction caused/contributed to the blood loss event. If the optiflux 180nre dialyzer is returned, a manufacturer evaluation may disassociate the dialyzer from having caused the serious adverse events. However, without the product investigation, discharge summary, and treatment records, this clinical investigation cannot disassociate the product from the serious adverse events.
 
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 (reported in mfr (b)(4)). The patient¿s treatment was restarted on the same hd machine, when a second blood leak alarm occurred (reported in mfr 1713747-2021-00457). A third attempt was made utilizing a different hd machine, however another blood leak alarm sounded, and a blood leak test strip confirmed the presence of blood in the dialysate again. Additionally, it was reported the return dialysate was visibly ¿tinted¿ yellow. The treatment was terminated a third time, and the patient¿s blood could not be returned, which resulted in 250 ml of blood loss (750 ml total). The inpatient nephrologist was contacted and ordered the discontinuation of hd therapy, and the transfusion of one unit of packed red blood cells. 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.
 
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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 Key12975643
MDR Text Key286765658
Report Number1713747-2021-00459
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? Yes
Is this a Product Problem Report? No
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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