MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 160NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 0500316E

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

Patient Problems Syncope (1610); Headache (1880); High Blood Pressure/ Hypertension (1908); Reaction (2414)

Event Date 11/01/2017

Event Type  Injury  

Manufacturer Narrative

A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

During review of received medical records, it was discovered the patient had been previously hospitalized in (b)(6) 2017 due to a dialyzer reaction during hemodialysis treatment.The medical records indicated the patient was six minutes into hemodialysis treatment when the patient developed high blood pressure and had a syncopal event, the patient awoke in dialysis but was taken to the emergency department (ed) for further evaluation as the patient was also encephalopathic.The medical records indicated the patient had "been previously admitted for dialyzer reaction and she has been ordered to be on baxter dialyzers only." the medical records additionally indicated the patient "was in her usual state of heath and mentation when she went to dialysis on the day of this admission.She apparently had an adverse reaction to a f160 dialyzer in the past causing syncope, headaches, and hypertension ((b)(6) 2017), but since then had no further adverse events on a different dialyzer.¿ follow up was made with the hemodialysis (hd) patient's clinic manager, who stated the patient was admitted to the hospital in (b)(6) 2017 due to hypertension and loss of consciousness during treatment while using a fresenius 160nre optiflux dialyzer, lot unknown.The clinic manager stated the patient was discharged on an unknown date and was able to return to the clinic to resume hemodialysis treatments without further issue.After the hospitalization event the patient was advised to dialyzer using only baxter dialyzers until it was determined why the patient had the reaction.The clinic manager stated the patient had not experienced any issues with any fresenius products in the past.Additional medical records were requested.

Manufacturer Narrative

Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.As such, a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.A search for potential lot number delivered to the patient was performed resulting in nine different lot numbers.An investigation of the device history records (dhr) was conducted by the manufacturer of potential related lots.There was one approved temporary deviation notice (dn) reported on eight of the lots and two approved temporary deviation notice (dn) reported on one lot, 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 reportedevent.The lot met all release criteria.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

During review of received medical records, it was discovered the patient had been previously hospitalized in (b)(6) 2017 due to a dialyzer reaction during hemodialysis treatment.The medical records indicated the patient was six minutes into hemodialysis treatment when the patient developed high blood pressure and had a syncopal event, the patient awoke in dialysis but was taken to the emergency department (ed) for further evaluation as the patient was also encephalopathic.The medical records indicated the patient had "been previously admitted for dialyzer reaction and she has been ordered to be on baxter dialyzers only." the medical records additionally indicated the patient "was in her usutal state of heath and mentation when she went to dialysis on the day of this admission.She apparently had an adverse reaction to a f160 dialyzer in the past causing syncope, headaches, and hypertension (last (b)(6) 2017), but since then had no further adverse events on a different dialyzer.¿ follow up was made with the hemodialysis (hd) patient's clinic manager, who stated the patient was admitted to the hospital in (b)(6) 2017 due to hypertension and loss of consciousness during treatment while using a fresenius 160nre optiflux dialyzer, lot unknown.The clinic manager stated the patient was discharged on an unknown date and was able to return to the clinic to resume hemodialysis treatments without further issue.After the hospitalization event the patient was advised to dialyzer using only baxter dialyzers until it was determined why the patient had the reaction.The clinic manager stated the patient had not experienced any issues with any fresenius products in the past.Additional medical records were requested.

Manufacturer Narrative

Conclusion: there is a temporal relationship between the patient event of syncope, hypertension and headache and hospitalization and the f160 hd dialyzer as evidenced by the patient¿s subsequent hd treatments utilizing baxter dialyzers with no issues.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.A supplemental medwatch report will be submitted upon completion of the investigation.

• Brand Name: OPTIFLUX 160NRE 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: 7400617
• MDR Text Key: 104530432
• Report Number: 1713747-2018-00110
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100149
• UDI-Public: 00840861100149
• Combination Product (y/n): N
• PMA/PMN Number: K002761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0500316E
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 06/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETAMINOPHEN; DOCUSATE SODIUM; FOLIC ACID; IPRATROPIUM; ISOSORBIDE MONONITRATE; LORAZEPAM; MIRTAZAPINE; NITROGLYCERIN; SEVELAMER CARBONATE; TRAZODONE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 61