MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 180NR DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 0500318N

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction (2414)

Event Date 09/01/2018

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. clinical investigation: on 09/23/2018, it was reported that on (b)(6) 2018 this patient on thrice weekly hemodialysis (hd) was suspected to have an allergic reaction to the optiflux 180nre dialyzer, characterized by hives during the last hour of hd treatment, despite the dialyzer being flushed with 2 liters of normal saline during treatment set up.During follow-up, it was confirmed the patient received a total of 25 milligrams (mg) benadryl during the hd treatment, which was part of the patient¿s standing hd orders.The patient was able to complete their treatment and the patient¿s hives resolved without further reported medical intervention.The patient has been on hd therapy for 7 months.Based on the available information, a possible causal association between the fresenius optiflux 180nre dialyzer and the patient¿s allergic reaction (characterized by hives during the last hour of hd treatment) cannot be excluded.It was reported, a dialyzer reaction was clinically suspected.Although rare, hypersensitivity or anaphylactoid reactions to optiflux dialyzers are a known risk during hemodialysis.There is no evidence of an optiflux nre dialyzer product deficiency or malfunction.The patient was subsequently switched to an optiflux nr dialyzer and the patient continued to experience hives (addressed in a sperate complaint file) suggesting a likely hypersensitivity reaction to the dialyzer membrane.

Event Description

A user facility clinic manager reported a patient who broke out in hives during the last hour of their (b)(6) 2018 hemodialysis treatment.The fresenius optiflux 180nre dialyzer finished assay was replaced with an optiflux 180nr dialyzer finished assembly, and the patient was administered 12.5mg of benadryl intravenously.The patient successfully completed treatment.The complaint device was reported to be available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

The reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.There was no indication of product nonacceptance, deviation, non-conformance, rework, labeling or process control failure during the manufacturing process which could be associated with the reported event.The lot met all release criteria.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.

Manufacturer Narrative

Event description updated per additional information received.Updated brand name to optiflux 180nr dialyzer finished assy.Changed lot number to unknown, changed catalog number to 0500318n.H4-removed device manufacture date.

Event Description

A user facility clinic manager reported a patient who broke out in hives during the last hour of their (b)(6) 2018 hemodialysis treatment using a fresenius optiflux dialyzer.The clinic manager initially reported that the patient was administered 12.5mg of benadryl twice intravenously during their (b)(6) 2018 treatment.Additionally, it was originally reported that the dialyzer used was a fresenius optiflux 180nre dialyzer.Upon further follow up with the clinical manager, it was confirmed that the (b)(6) 2018 treatment was with a fresenius optiflux 180nr dialyzer (rather than the optiflux 180nre as initially reported), and that the patient was administered benadryl intravenously (unspecified amount) prior to treatment.It was also confirmed that the dialyzer was flushed with 2 liters of normal saline solution prior to treatment.The patient successfully completed treatment on the machine, and continues with their scheduled hemodialysis treatments.The complaint device was reported to be available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

Clinical investigation: it was reported that on (b)(6) 2018 this patient on thrice weekly hemodialysis (hd) was suspected to have an allergic reaction to the optiflux 180 nr dialyzer, characterized by hives during the last hour of hd treatment, despite the dialyzer being flushed with 2 liters of normal saline during treatment set up.During follow-up.It was confirmed the patient received a total of 25 milligrams (mg) benadryl during the hd treatment, which was part of the patient¿s standing hd orders.The patient was able to complete their treatment and the patient¿s hives resolved without further reported medical intervention.Based on the available information, a possible causal association between the fresenius optiflux 180nr dialyzer and the patient¿s allergic reaction (characterized by hives during the last hour of hd treatment) cannot be excluded.It was reported, a dialyzer reaction was clinically suspected.Although rare, hypersensitivity or anaphylactoid reactions to optiflux dialyzers are a known risk during hemodialysis.There is no evidence of an optiflux nr dialyzer product deficiency or malfunction.The patient subsequently continued to experience hives during hemodialysis using the optiflux nr dialyzer (addressed in a sperate complaint file) suggesting a likely hypersensitivity reaction to the dialyzer membrane.

Manufacturer Narrative

Correction: mfr site 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 with the reported catalog number delivered to the patient¿s dialysis unit in the three months prior to the complaint occurrence date.Six lots were found to have been delivered in this time period.A production records review was performed on the reported lots.An investigation of the device history records (dhr) was conducted by the manufacturer.There was one approved temporary deviation notice (dn) reported on one of the lots which were unrelated to the complaint event.There was no indication of product nonacceptance, deviation, non-conformance, rework, labeling or process control failure during the manufacturing process which could be associated with the reported event.The lots met all release criteria.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.

• Brand Name: OPTIFLUX 180NR DIALYZER FINISHED ASSY.
• 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: 7955558
• MDR Text Key: 123371406
• Report Number: 1713747-2018-00374
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K002761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 0500318N
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Device Age: MO
• Date Manufacturer Received: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 103