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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 Problems Hypersensitivity/Allergic reaction (1907); High Blood Pressure/ Hypertension (1908); Nausea (1970); Vomiting (2144); Reaction (2414)
Event Date 01/20/2018
Event Type  Injury  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.   clinical investigation: a clinical investigation was performed to identify a causal relationship between the hemodialysis (hd) treatment and the adverse event reported. Based on the provided information, there is a temporal relationship between the fresenius optiflux 180nre dialyzer and the reported event(s) of hypotension, faint heart rate, feeling hot, feeling flushed and vomiting. In rare cases, persons with hypersensitivity to the polysulphone membranes and/or e-beam sterilization are at risk for anaphylactic or anaphylactoid reactions. Hypersensitivity reactions may cause mild to severe signs and symptoms, including: itching, flushing, hives, swelling, fever, leukopenia, hypotension, hypertension, shortness of breath with wheezing, arrhythmias, and/or respiratory arrest.
 
Event Description
A user facility clinic manager reported a dialyzer reaction that occurred approximately 47 minutes into the patient¿s hemodialysis (hd) treatment. The patient stated their face was feeling hot and asked the nursing staff to check them, at which point, the patient became nauseous and vomited undigested food. The blood flow rate (bfr) had remained constant at 250 ml/min. A blood pressure was obtained and found to be 168/85. A 350 ml normal saline (ns) bolus was administered and the treatment was discontinued. The blood pressure after the saline bolus was 184/92 at 16:20. Between 16:00 and 16:20 the patient stated they were feeling hot and flushed to staff and began to vomit a second time. The patient was sent to the emergency room (er) for evaluation. The patient was alert and oriented upon discharge to the er. It is unknown how the patient was transported to the hospital. Following this event, the patient was subsequently hospitalized for 1 week (exact dates unknown), and additional details regarding the patient¿s hospital course are unknown as the discharge paperwork is not available. The clinic manager reported the patient did receive hd therapy while hospitalized utilizing a fresenius optiflux 180nr with good effect. Per the clinic manager, it was suspected the patient was having a reaction to the type of sterilization process used on the optiflux 180nre. It is unknown if any additional fresenius device(s) or product(s) were utilized during the hospitalization. Upon return to the outpatient dialysis clinic, the patient was permanently transitioned to the optiflux 180nr dialyzer and has since completed treatments with no further issues. The lot number of the device was unavailable. The clinic manager confirmed that the complaint device was discarded and is not available to be returned to the manufacturer for evaluation.
 
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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
475 west 13th street
ogden UT 84404
Manufacturer Contact
thomas c. johnson
920 winter st.
waltham, MA 02451
7816999499
MDR Report Key7277286
MDR Text Key100283894
Report Number1713747-2018-00056
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861100156
UDI-Public00840861100156
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
Type of Report Initial,Followup
Report Date 09/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0500318E
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device Age MO
Event Location No Information
Date Manufacturer Received09/04/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 02/16/2018 Patient Sequence Number: 1
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