FDA Adverse Event Injury Summary report: N

NIPRO ELISIO-H DIALYZER

MDR report key: 10955690 · Received December 6, 2020

Report

Report Number
1056186-2020-00020
Event Type
Injury
Date Received
December 6, 2020
Date of Event
November 10, 2020
Report Date
December 6, 2020
Manufacturer
NIPRO CORPORATION (ODT)
Product Code
KDI
UDI-DI
00383790007122
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
IL, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

ON (B)(6) 2020, A 2ND PATIENT SENT TO THE ICU AFTER DIALYSIS TREATMENT. NO FURTHER INFORMATION WAS PROVIDED. UNKNOWN DETAILS OF ADVERSE EVENT OR PATIENT SYMPTOMS. CLINICAL SPECIALIST WILL CONTINUE TO ATTEMPT TO OBTAIN ADDITIONAL INFORMATION. ADDITIONAL INFORMATION RECEIVED ON 11/23/2020: PATIENT (B)(6); (B)(6)-YEAR-OLD FEMALE, STARTED DIALYSIS TREATMENT AT 630AM ON (B)(6) 2020, SET FOR 3.5H AS ORDERED, BP 104/65; HR 97. PATIENT COMPLAINED OF HEARTBURN DURING DIALYSIS. PATIENT STATED SHE HAS THIS OCCASIONALLY AT HOME AND TAKES SOME MEDS FOR IT. RENAL PHYSICIAN NOTIFIED OF PATIENT'S COMPLAINTS. PATIENT WAS STARTED ON OXYGEN 3L/NASAL CANNULA DUE TO COMPLAINTS OF SHORTNESS OF BREATH. O2(OXYGEN) SATURATION CHECKED, 100% WITH OXYGEN. PATIENT WAS RESTING DURING HD WITH NO FURTHER DISTRESS. AT APPROXIMATELY AN HOUR AND A HALF INTO TREATMENT, RENAL PHYSICIAN WAS MAKING ROUNDS, SEEN AND EXAMINED PATIENT, WITH ORDERS TO STOP HD, DRAW LABS: CBC, LIPASE, TROPONIN, ELECTROLYTES AND SENT TO EMERGENCY ROOM FOR FURTHER EVALUATION/TREATMENT. HD ENDED 2.5 HOURS INTO TREATMENT. NEEDLES WERE REMOVED WITH NO SEVERE BLEEDING. BP 118/68; HR 98; TEMP: 97.8. TREATMENT INFORMATION: NUMBER OF HOURS: 2.5 ACCESS; BFR: 400; DFR: 600; HEPARIN: BOLUS; HOW LONG ON DIALYSIS: 2.5 HOURS INTO A 3.5 PRESCRIBED TREATMENT; DIALYZER: ELISIO 19H DIALYZER; MACHINE: PHOENIX GAMBRO.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1421095 NIPRO ELISIO-H DIALYZER DIALYZER KDI NIPRO CORPORATION (ODT) DD+ELISIO-19H 19K21B 00383790007122

Patients

Seq Age Sex Outcome Treatment
1 75 YR Hospitalization