FDA Adverse Event Injury Summary report: N

NIPRO ELISIO-H DIALYZER

MDR report key: 10955683 · Received December 6, 2020

Report

Report Number
1056186-2020-00019
Event Type
Injury
Date Received
December 6, 2020
Date of Event
November 3, 2020
Report Date
December 6, 2020
Manufacturer
NIPRO CORPORATION (ODT)
Product Code
KDI
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
IL, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

ON 11/13/2020: PATIENT COMPLAINED OF ABDOMINAL PAIN DURING TREATMENT. PATIENT WAS ADMITTED TO THE ICU. FACILITY MANAGER QUESTIONED HOW THE DIALYZERS ARE STERILIZED, FACILITY MANAGER DOES NOT THINK THE ADVERSE EVENT WAS DUE TO THE DIALYZER SINCE THE PATIENT HAS BEEN USING THE ELISIO DIALYZERS FOR OVER A YEAR WITHOUT ISSUES. PATIENT (B)(6), STARTED DIALYSIS TREATMENT AT 07:04 ON (B)(6) 2020, COMPLETED TREATMENT FOR FOUR HOURS AS PRESCRIBED. LEFT THE UNIT TO GO BACK TO ASSISTED LIVING. PATIENT REPORTED OF LETHARGY BY NURSING. VETERAN REPORTS HE RETURNED FROM HD AND HIS LEFT ARM IS PAINFUL WITH REDUCED ROM (RANGE OF MOTION), A CHANGE FROM EARLIER THIS MORNING. HE NOTES HE FEELS "FAINT" AND HAS INDIGESTION WHICH HAS IMPROVED WITH (B)(6). HE DENIES CHEST PAIN OR PRESSURE, RADIATING PAIN, JAW PAIN. FEELS CHILLED AND TIRED. VITALS: BP 136/69, P 87, 91% OXYGEN IN ROOM AIR AND TEMPERATURE OF 100.2. SENT VETERAN TO EMERGENCY ROOM. FROM EMERGENCY ROOM, PATIENT'S BLOOD SPECIMEN CONTINUES TO BE HEMOLYZED UPON ASPIRATION. PATIENT'S BLOOD PERSISTS WITH HEMOLYSIS WITH METHEMOGLOBINEMIA. METHEMOGLOBIN LEVEL OF 12.3. TREATMENT INFORMATION: NUMBER OF HOURS: 4. BFR: 400. DFR: 600. ANY MEDICATIONS ADMINISTERED: EPOGEN 5000 UNITS. PATIENT'S ACCESS: FISTULA. MACHINE: PHOENIX GAMBRO.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1421056 NIPRO ELISIO-H DIALYZER DIALYZER KDI NIPRO CORPORATION (ODT) DD+ELISIO-25H 20D02E

Patients

Seq Age Sex Outcome Treatment
1 71 YR Hospitalization