FDA Adverse Event Injury Summary report: N

NIPRO ELISIO-H DIALYZER

MDR report key: 14469500 · Received May 23, 2022

Report

Report Number
1056186-2022-00002
Event Type
Injury
Date Received
May 23, 2022
Date of Event
April 19, 2022
Report Date
May 23, 2022
Manufacturer
NIPRO CORPORATION (ODT)
Product Code
KDI
UDI-DI
00383790007108
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
MI, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

58 MINUTES INTO A TWO-HOUR DIALYSIS TREATMENT THE AFFECTED PATIENT STARTED VOMITING AND SUBSEQUENTLY HAD A WITNESSED GRAND-MAL SEIZURE. THIS LASTED 1-2 MINUTES AND THEN SUBSIDED. THE TREATMENT WAS ENDED WITH A TOTAL OF 489 ML UF(ULTRAFILTRATION). EMS WAS DISPATCHED AND BY THE TIME THEY ARRIVED IN THE FACILITY THE PATIENT WAS FULLY CONSCIOUS AND RECOVERED FROM THE EVENT. THE NURSE NOTED THAT THERE WAS NO CHANGE IN VITAL SIGNS BEFORE THE EVENT, AND NO INDICATION TO HER THAT THERE WAS AN IMPENDING EVENT. THIS PATIENT IS AN ESTABLISHED DIALYSIS PATIENT WITH NO HISTORY OF SEIZURES. PER THE NURSE, AFTER THE EVENT THE PATIENTS BLOOD PRESSURE WAS SLIGHTLY ELEVATED, BUT WITHIN NORMAL RANGE. THE PATIENT WAS TAKEN TO THE HOSPITAL AND CLEARED TO RETURN BACK TO THE NURSING HOME THAT SAME DAY. THE PATIENT RECEIVED DIALYSIS TREATMENTS WEDNESDAY(B)(6) 2022, THURSDAY (B)(6) 2022 AND FRIDAY (B)(6) 2022 WITH NO ADVERSE EVENTS. (B)(6) 2022: RN SAID PATIENT DIALYZED WITH NO ISSUES. PATIENT HAD HISTORY OF STROKE BUT NO HISTORY OF SEIZURES. PER NURSE, NO MEDICATIONS WERE GIVEN DURING THE TREATMENT WHEN THE EVENT HAPPENED, AND NO NEW MEDICATION WAS STARTED. PATIENT HAS CVC BUT HAD AVF SURGERY (B)(6) 2022. VITAL SIGNS: PRE TX: BP = 103/48, PULSE = 90, TEMP = 97.5, RR = 20 START OF TX: BP = 137/67, P = 81 DURING THE EVENT: BP = 142/119, P = 81 POST TX: 175/76, P = 95, TEMP = 96.2, RR = 22 EDW: 100.5 KG. PT CAME WITH 100.8 KG BUT HAS BEEN LOSING WEIGHT AND THEY HAVE HAD TO CHANGE EDW FOR SEVERAL TIMES FOR OVER A MONTH. NURSE INFORMED THE TEAM THAT PATIENT HAD BEEN LOSING WEIGHT AND IS ON DIETARY EVALUATION. OTHER DEVICES USED DURING EVENT:: NIPRO ELISIO 15H: DD+ELISIO-15H - LOT # 21J14F NIPRO BLOOD TUBING SET: PRODUCT CODE- BL+A430/V912 - LOT # 20F15 CITRIC ACID: AC -200 - NURSE WAS NOT SURE WHAT WAS THE LOT # USED DURING THE TREATMENT. FOLLOWING LOT #S IN THE UNIT: N2B009, N2B007 AND N1H007.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1618351 NIPRO ELISIO-H DIALYZER DIALYZER KDI NIPRO CORPORATION (ODT) DD+ELISIO-15H 21J14F 00383790007108

Patients

Seq Age Sex Outcome Treatment
1 Unknown Hospitalization