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 Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914); Itching Sensation (1943); Rash (2033)

Event Date 10/24/2023

Event Type  Injury  

Event Description

On 29/nov/2023 fresenius received a voluntary medwatch (mw5147915) reporting a hemodialysis (hd) patient dialyzer reaction.Additional information was obtained through follow-up with the clinical manager.On 24/oct/2023 this patient arrived at the clinic for their first hd treatment.The patient¿s pre-vital signs were as follows: blood pressure (bp) 206/107, pulse 57, respiration 16, and temperature 99.7.The patient was to dialyze for a scheduled four-hour treatment utilizing the optiflux 160nre dialyzer via a tunneled central venous catheter (cvc).The patient¿s treatment initiated at 0735 and approximately five minutes into the treatment, the patient developed itching and a rash on their lower extremities.Benadryl 50mg intravenous push (ivp) was administered.The patient¿s bp was 166/103 with a pulse of 57.The symptoms resolved briefly, but then returned.The patient became short of breath (sob) and was administered solumedrol 125mg ivp and oxygen (o2) at 3l was provided via nasal cannula (nc).The patient subsequently became hypotensive with systolic bp dropping into the 80s (exact bp values unknown).A bolus of 800ml of normal saline (ns) was administered.Treatment was discontinued at 0809 per the physician and the patient was monitored for approximately 20 minutes.The symptoms did not resolve and 911 was called.Epinephrine 1:1000 intramuscular (im), benadryl 50mg oral (po), and solumedrol 125mg im were administered.The patient remained alert and oriented and was transferred to hospital.Vital signs at time of transfer were bp 153/86, pulse 94, resp 24, o2 sat 98% on 3l o2.The patient was admitted to the hospital on (b)(6) 2023 through (b)(6) 2023.The patient ran several hd treatments during the hospitalization with the recommended optiflux 180nr dialyzer without further reactions noted.The patient returned to the clinic for treatment on (b)(6) 2023.The optiflux 160nre dialyzer was added as a patient allergy.

Manufacturer Narrative

Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Based on the available information, there is a temporal and a likely causal relationship between the fresenius optiflux 160nre dialyzer and the patient¿s reaction (characterized by itching and rash with subsequent sob and hypotension with hospitalization) as the reaction was reported to have occurred approximately 5 minutes after the initiation of treatment.Although rare, hypersensitivity or anaphylactoid reactions to dialyzers are a known risk during hemodialysis.The exposure of the patient¿s blood to a foreign substance present in the extracorporeal circuit is the result of an immunoallergic response.This was further supported by the patient¿s symptoms not returning once the dialyzer was switched to the optiflux 180nr dialyzer.There is no evidence of an optiflux 160nre dialyzer product deficiency or malfunction, but rather a bio-incompatibility between the patient and the membrane material.However, although there is no allegation or evidence of a product malfunction or deficiency the optiflux 160nre dialyzer cannot be excluded as causing or contributing to the patient¿s adverse event.

Manufacturer Narrative

Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.During the lot history review it was noted that there was one other complaint reported against the lot.The complaint is not associated with the current event.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.There were multiple approved temporary deviation notices (dn) reported on the 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 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.

Event Description

On 29/nov/2023, fresenius received a voluntary medwatch (mw5147915) reporting a hemodialysis (hd) patient dialyzer reaction.Additional information was obtained through follow-up with the clinical manager.On (b)(6) 2023, this patient arrived at the clinic for their first hd treatment.The patient¿s pre-vital signs were as follows: blood pressure (bp) 206/107, pulse 57, respiration 16, and temperature 99.7.The patient was to dialyze for a scheduled four-hour treatment utilizing the optiflux 160nre dialyzer via a tunneled central venous catheter (cvc).The patient¿s treatment initiated at 0735 and approximately five minutes into the treatment, the patient developed itching and a rash on their lower extremities.Benadryl 50mg intravenous push (ivp) was administered.The patient¿s bp was 166/103 with a pulse of 57.The symptoms resolved briefly, but then returned.The patient became short of breath (sob) and was administered solumedrol 125mg ivp and oxygen (o2) at 3l was provided via nasal cannula (nc).The patient subsequently became hypotensive with systolic bp dropping into the 80s (exact bp values unknown).A bolus of 800ml of normal saline (ns) was administered.Treatment was discontinued at 0809 per the physician and the patient was monitored for approximately 20 minutes.The symptoms did not resolve and 911 was called.Epinephrine 1:1000 intramuscular (im), benadryl 50mg oral (po), and solumedrol 125mg im were administered.The patient remained alert and oriented and was transferred to hospital.Vital signs at time of transfer were bp 153/86, pulse 94, resp 24, o2 sat 98% on 3l o2.The patient was admitted to the hospital on (b)(6) 2023 through (b)(6) 2023.The patient ran several hd treatments during the hospitalization with the recommended optiflux 180nr dialyzer without further reactions noted.The patient returned to the clinic for treatment on (b)(6) 2023.The optiflux 160nre dialyzer was added as a patient allergy.

• 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; director, site quality; 475 west 13th street; ogden UT 84404
• Manufacturer (Section G): OGDEN MANUFACTURING PLANT; director, site quality; 475 west 13th street; ogden UT 84404
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 18258352
• MDR Text Key: 329624425
• Report Number: 0001713747-2023-00832
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100149
• UDI-Public: 00840861100149
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/17/2024

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: 0500316E
• Device Lot Number: 23KU06037
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/04/2023
• Supplement Dates Manufacturer Received: 01/15/2024
• Supplement Dates FDA Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS HEMODIALYSIS MACHINE; FRESENIUS HEMODIALYSIS MACHINE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male