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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT DIALYZER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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OGDEN MANUFACTURING PLANT DIALYZER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number OPTIFLUX 200NR DIALYZER FINISHED ASSBLY
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Hypersensitivity/Allergic reaction (1907); Chills (2191); Reaction (2414); Blood Loss (2597)
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative
Clinical review: the documentation in this complaint file supports a probable association between the fresenius optiflux 200nr dialyzer and the patient¿s reported event(s) of chills, fatigue, gi bleeding and thrombocytopenia, as it appears the patient was changed to a non fresenius dialyzer (date unknown) with no additional documented or communicated complaint(s). Additionally, there is no allegation against any fresenius product(s) or device(s) having malfunctioned or not performed as expected as the patient completed hd therapy each time as scheduled. It is important to note the patient was taking plavix (dosage unknown) during the time of the event, for which medication induced thrombocytopenia is a known complication. Additionally, in rare cases, persons with hypersensitivity to the polysulphone membranes and/or e-beam sterilization are at risk for developing thrombocytopenia. It cannot be determined if either of these were the causal factor in the thrombocytopenia, as the patient discontinued the use of plavix and the optiflux 200nh dialyzer in close proximity, which resulted in no additional issues. A supplemental report will be submitted upon completion of the plant¿s investigation.
 
Event Description
Clinic response on an unrelated customer experience indicates that the hemodialysis patient encountered a dialyzer reaction, chills, fatigue, gastrointestinal bleeding and thrombocytopenia after 27 hemodialysis treatments. Exact dates unknown. Documentation in related files states the patient became thrombocytopenic with each dialysis treatment and would bleed from his arterial/venous (av) malformations (specifics unknown). The communication revealed the patient was receiving hd (treatment details unknown) therapy utilizing an optiflux 200nr dialyzer. It was reported a ¿blue top tube¿ (date of collection and test(s) unknown) was utilized to confirm the low platelet count (value unknown) was not caused by ¿clumping. ¿ the nephrologist attributes the decreased platelet count to a dialyzer (polysulfone) reaction as the patient¿s platelet count was within normal limits (normal range
=
150,000 to 450,000 mcl) prior to beginning hd in (b)(6) 2017. Additionally, it was reported the patient receives no heparin before or during dialysis. At the time of the event(s) the patient had recently underwent a coronary artery stent, and was taking plavix (dosage and frequency unknown) and aspirin (dosage and frequency unknown). The patient required blood transfusions after each dialysis treatment (exact number of occurrences unknown). Additionally the patient began experiencing gastrointestinal (gi) bleeding (severity unknown), and testing (test types unknown) could not determine the source of the gi bleeding. As a result, the patient was taken off plavix and aspirin. The nephrologist consulted his partner and they noted the patient¿s platelet count dropped significantly after treatment, and felt the patient¿s symptoms could be caused by the dialyzer. The patient¿s symptoms improved/resolved when the clinic started using non fresenius dialyzers.
 
Manufacturer Narrative
The reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation. As no lot number was provided for this complaint, a search was performed to obtain all lot numbers/products delivered to the patient¿s dialysis unit in the three months prior to the complaint occurrence date. It was noted that the clinic was not delivered any f200nr dialyzer product (as reported by the complainant). The mechanism by which the facility obtained the f200nr dialyzers related to the complaint event was not provided during follow up. No device history record (dhr) review was performed since the lot number is unknown. A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device. Therefore, the complaint is not confirmed. Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand NameDIALYZER
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 Key7616116
MDR Text Key111620812
Report Number1713747-2018-00225
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K002277
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberOPTIFLUX 200NR DIALYZER FINISHED ASSBLY
Device Catalogue Number0500320N
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received07/18/2018
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

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