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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 Syncope (1610); Cardiopulmonary Arrest (1765); High Blood Pressure/ Hypertension (1908); Nausea (1970); Reaction (2414); Loss of consciousness (2418)
Event Date 01/19/2018
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 patient event of nausea, loss of consciousness and subsequent hospitalization and the fresenius optiflux 180nre dialyzer. 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 13 minutes into the patient¿s hemodialysis (hd) treatment. At this time, the patient became unresponsive. A sternal rub was given with no response and cardiopulmonary resuscitation (cpr) was initiated. After 15 compressions, the patient responded, and cpr was stopped. Emergency medical services (ems) arrived and transported the patient to the emergency room (er). Per the information in the discharge summary, the patient reported being nauseous prior to treatment and arrival at the clinic, and took a pill (type, dose, and strength unknown) for the nausea. The patient stated feeling nauseated during hd treatment, and recalls a feeling of blackness and passing out. The patient stated remembering the compressions. Per ems, the patient never lost a pulse. The patient was admitted for further evaluation and placed on telemetry monitoring which did not result in any significant arrhythmias. The patient underwent magnetic resonance imaging (mri) of the brain with no acute findings. The patient¿s dose of procardia was increased (dose unknown) due to uncontrolled hypertension. The patient is non-compliant with medication and was given extensive counseling regarding medication compliance. An echocardiogram (echo) was ordered, but the patient insisted on being discharged before the echo was completed. The patient did not experience any recurrence of the symptoms during hospitalization. The patient was discharged to home on (b)(6) 2018 tolerating ambulation without any orthostatic symptoms. Per the clinic manager, the patient was new to in-center hd treatments and previously completed home hd treatments with no issues. The clinic manager stated that the patient has returned to home hd treatments with no reported issues. The clinic manager suspected that the patient had a dialyzer reaction to the optiflux 180nre dialyzer. The clinic manager stated that the patient was changed to a new dialyzer, however, it is unknown what dialyzer the patient was transitioned to for home treatments. The lot number of the complaint 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 Key7286956
MDR Text Key100608789
Report Number1713747-2018-00060
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 Received02/21/2018
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: 02/21/2018 Patient Sequence Number: 1
Treatment
DEXTROSE (100); FRESENIUS 2008T MACHINE; FRESENIUS COMBISET BLOODLINES; GRANUFLO (G2231) 2K; NORMAL SALINE (1000ML)
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