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

Catalog Number 0500318E

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Vomiting (2144); Reaction (2414); Loss of consciousness (2418); Loss Of Pulse (2562); Diminished Pulse Pressure (2606)

Event Date 01/11/2018

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 fresenius optiflux 180nre dialyzer and the reported event(s) of nausea, vomiting, hypotension, loss of consciousness, and subsequent hospitalization.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 34 minutes into the patient¿s first hemodialysis (hd) treatment.The patient stated they were feeling nauseous.The blood pressure was reported to be 100/50.A 250 ml normal saline (ns) bolus was administered, at which point the patient began vomiting.The blood pressure after the saline bolus was reported to be 156/76 at 15:34.Approximately 1 minute later the patient became unconscious.At 15:35 a code response was initiated.The patient¿s pulse was reported to be faint or absent, thus cardiopulmonary resuscitation (cpr) measures were initiated.After 3 compressions, the patient became alert with a strong pulse.Oxygen was administered at maximum liter/min via facemask.By 15:38 the patient was responding verbally, with a blood pressure of 177/97.Automated external defibrillator (aed) pads were applied, however no shock was advised.Emergency medical services (ems) arrived at 15:43 and transported the patient to the emergency room (er).Following this event, the patient was subsequently hospitalized for 1 week (exact dates unknown), and additional details regarding the patient¿s hospital course are unknown as the discharge paperwork is not available.The clinic manager reported the patient did receive hd therapy while hospitalized utilizing a fresenius optiflux 180nr with good effect.Per the clinic manager, it was suspected the patient was having a reaction to the type of sterilization process used on the optiflux 180nre.It is unknown if any additional fresenius device(s) or product(s) were utilized during the hospitalization.The nurse reported that the patient has been permanently transitioned to the optiflux 180nr dialyzer and has since completed treatments with no further issues.The lot number of the 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.

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 with the reported catalog number delivered to the patient¿s dialysis unit in the three months prior to the complaint occurrence date.Eighteen 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 were multiple approved temporary deviation notices (dn) reported on four of the lots which were unrelated to the complaint event.There was one approved dn on the remaining fourteen lots which was unrelated to the reported 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.

• Brand Name: OPTIFLUX 180NRE 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: 7277401
• MDR Text Key: 100309031
• Report Number: 1713747-2018-00057
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100156
• UDI-Public: 00840861100156
• 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
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0500318E
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 02/01/2018
• Initial Date FDA Received: 02/16/2018
• Supplement Dates Manufacturer Received: 09/04/2018
• Supplement Dates FDA Received: 09/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 77