FDA Adverse Event Injury Summary report: N

NIPRO ELISIO-H DIALYZER

MDR report key: 23303961 · Received October 15, 2025

Report

Report Number
9610987-2025-00025
Event Type
Injury
Date Received
October 15, 2025
Date of Event
August 14, 2025
Report Date
October 15, 2025
Manufacturer
NIPRO CORPORATION (ODT)
Product Code
KDI
PMA / PMN Number
K131935
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
CH
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

APPROXIMATELY 10 TO 30 MINUTES AFTER STARTING PRE-DILUTION HDF TREATMENT, FOUR PATIENTS DEVELOPED SYMPTOMS INCLUDING CHEST TIGHTNESS, SHORTNESS OF BREATH, AND HYPOTENSION. STAFF TREATED THIS AS AN ALLERGIC REACTION, GIVING IV DEXAMETHASONE AND HIGH CONCENTRATION GLUCOSE BUT SOME PATIENTS SHOWED NO IMPROVEMENT IN SYMPTOMS. FOR PATIENTS WHERE IMPROVEMENT WAS CONFIRMED, PERFORMING HD TREATMENT USING CTA 15G SIGNIFICANTLY ALLEVIATED SYMPTOMS, AND TREATMENT WAS COMPLETED SAFELY. ALL FOUR PATIENTS HAD PREVIOUSLY RECEIVED HDF TREATMENT USING ELIOS-17H. HOWEVER, DUE TO HEALTHCARE POLICY RESTRICTIONS, HDF TREATMENT WAS ONLY AVAILABLE ONCE PER MONTH. ONE OF THE FOUR PATIENTS SHOWED NO IMPROVEMENT IN SYMPTOMS. FOR THE PATIENT WHO DID NOT SHOW IMPROVEMENT, SYMPTOMS IMPROVED BY USING CTA 15G. ALL PATIENTS HAVE NOW RECOVERED FROM THEIR SYMPTOMS. HOWEVER, ELISIO-H IS NOT CURRENTLY BEING USED. THIS HOSPITAL TYPICALLY PERFORMS HD THERAPY THREE TIMES PER WEEK AND HDF THERAPY ONCE PER MONTH. THE ULTRAFILTRATION RATE DURING TREATMENT REMAINED WITHIN THE NORMAL RANGE. COMBINATION MEDICAL DEVICE USED: DIALYSIS MACHINE: B.BRAUN DIALOG; NO INFORMATION ON OTHER DEVICES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2357943 NIPRO ELISIO-H DIALYZER DIALYZER KDI NIPRO CORPORATION (ODT) ELISIO-17H 25B17C

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown Other