MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 200NR DIALYZER FINISHED ASSBLY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number PLATELET COUNTS (VALUES AND DATES UNKNOWN).

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

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

Plant investigation: 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.

Event Description

".".

• Brand Name: OPTIFLUX 200NR DIALYZER FINISHED ASSBLY.
• 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
• MDR Report Key: 7611064
• MDR Text Key: 111429878
• Report Number: 1713747-2018-00210
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100132
• UDI-Public: 00840861100132
• Combination Product (y/n): N
• PMA/PMN Number: K002277
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PLATELET COUNTS (VALUES AND DATES UNKNOWN).
• Device Catalogue Number: 0500320N
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: MO
• Date Manufacturer Received: 07/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASPIRIN; PLAVIX
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR