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

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.

• Brand Name: DIALYZER
• Type of Device: DIALYZER, 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 Key: 7615707
• MDR Text Key: 111562346
• Report Number: 1713747-2018-00220
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002277
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: OPTIFLUX 200NR DIALYZER FINISHED ASSBLY
• Device Catalogue Number: 0500320N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 07/18/2018
• 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

Patient Treatment Data

Date Received: 06/19/2018 Patient Sequence Number: 1

Treatment

ASPERIN; PLAVIX