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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
Catalog Number 0500318E
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemolysis (1886)
Event Date 06/19/2019
Event Type  Injury  
Manufacturer Narrative
Clinical review: a temporal relationship exists between the hemodialysis treatments performed on (b)(6) 2019 using the 2008 t hemodialysis machine, fresenius bloodlines, fresenius dialyzers, granuflo acid, naturalyte 4000 bicarbonate, fresenius clic blood chamber and the patient¿s hemolysis event requiring blood transfusion. The clinic investigation has not successfully identified the source of the hemolysis. There is no objective evidence of any user error, non-compliance to standard operating procedure, chemical/toxic exposures, or any thermal/mechanical causes. The manufacturer¿s product analysis is pending at the time of this clinical investigation. Therefore, any concomitant fresenius products utilized cannot be excluded as a possible causal or contributory factor in the event. There have been no reported defects with any fresenius products used in relation to this event. There have not been any new reports of any additional hemolysis cases associated with use of fresenius products. The granuflo mix and bicarbonate mix tested had a normal specific gravity according to documentation on clinic logs. Moreover, it was reported there were no conductivity alarms on the 2008 t machines. Electrolyte panels of the final dialysate were also within normal limits. The patient sodium levels were normal. It appears unlikely an osmolar insult from the acid or bicarbonate occurred. The patients were not using the same size or lot of optiflux dialyzers which suggests the dialyzers did not cause the hemolysis event due to the degree of variability. There were no reported blood leaks or defects with any of the optiflux dialyzers used. All 2008 t machines passed pre-treatment and post -event functionality testing. There were no unexpected machine alarms in relation to the event. The cause of the hemolysis cannot be determined. The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
An area technical operations manager (atom) reported that a hemodialysis patient experienced hemolysis event. Upon follow up, the hemolysis event appears to have occurred between (b)(6) 2019. The patient¿s pre-hemodialysis treatment labs were drawn on (b)(6) 2019 without any reported issues with the lab specimen. On (b)(6) 2019, the clinic manager reviewed the lab results which were drawn post hemodialysis treatment and noticed the patient had a drop in their baseline hemoglobin from 12. 8 to 11. 2. The patient required a blood transfusion on (b)(6) 2019 outpatient due to an unknown surgical procedure; however, they were not admitted to the hospital. The patient was reported dialyzing with a fresenius 2008t hemodialysis machine, fresenius bloodlines, fresenius dialyzers, fresenius granuflo acid (2551) 2. 0 potassium/2. 5 calcium, fresenius naturalyte 4000 bicarbonate, fresenius clic blood chamber and fresenius normal saline. It was reported there were no visual defects or anything unexpected with any of the fresenius products used, as well as no machine alarms, clotting events and/or dialyzer leaks in relation to the hemolysis event. It was reported there was nothing unusual in any of the hemodialysis treatments. There were no visible signs of hemolysis during any treatment such as, translucent/cherry colored blood, which is typical with hemolysis in hemodialysis or any patient symptoms. The patient completed all their hemodialysis treatments during the timeframe without any adverse effect. Currently, the cause of the hemolysis event is unknown. The actual and companion samples of the fresenius products used between (b)(6) 2019 have been sent to the manufacturer for further investigation.
 
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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
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 Key8808408
MDR Text Key151627713
Report Number1713747-2019-00229
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 10/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2022
Device Catalogue Number0500318E
Device Lot Number19BU03011
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/05/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Device Age MO
Event Location No Information
Date Manufacturer Received10/28/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/22/2019
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: 07/19/2019 Patient Sequence Number: 1
Treatment
2008T MACHINE; FRESENIUS BLOODLINES; FRESENIUS CLIC BLOOD CHAMBER; FRESENIUS GRANUFLO ACID; FRESENIUS NATURALYTE 4000 BICARBONATE; FRESENIUS NORMAL SALINE
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