FDA Adverse Event Death Summary report: N

CONTINUOUS RENAL REPLACEMENT THERAPY(CRRT)

MDR report key: 23244252 · Received October 8, 2025

Report

Report Number
MW5176983
Event Type
Death
Date Received
October 8, 2025
Date of Event
September 25, 2025
Report Date
October 2, 2025
Manufacturer
UNK
Product Code
KDI
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
MA, US
Reporter Occupation
PHYSICIAN
Health Professional
Yes

Narratives

Description of Event or Problem · 0

GRADE: 5 ATTRIBUTIONS: UNRELATED TO GEMCITABINE, CISPLATIN, DURVALUMAB, YTTRIUM-90 EVENT: DEATH SUBJECT (B)(6) IS A 70-YEAR-OLD WOMAN WITH METASTATIC INTRAHEPTIC CHOLANGIOCARCINOMA WHO CONSENTED TO PARTICIPATE IN THE DF/HCC TRIAL (B)(4), (B)(6) ON (B)(6) 2025. THE SUBJECT WAS SEEN ON (B)(6) 2025 FOR C5D8 MOST RECENTLY. SUBJECT (B)(6) PRESENTED TO THE ER AT (B)(6) BY EMERGENCY SERVICES FOR A FALL, ALONG WITH SUSTAINED HEMATOMA WITH A 2CM LACERATION TO OCCIPITAL SCALP, WHICH WAS SECURED WITH 3 STAPLES. THE SUBJECT DENIES LOSS OF CONSCIOUSNESS, A CT HEAD IMAGING WITHOUT ACUTE INJURIES. UPON FURTHER WORKUP, THE SUBJECT NOTED TO HAVE ELEVATED CREATININE/BLOOD UREA NITROGEN (BUN), HYPOKALEMIA, HYPERPHOSPHATEMIA, WORSENING ASCITES, ANEMIA, ELEVATED LIVER FUNCTION (LFTS), LOW ALBUMIN AND PERIODS OF CONFUSION, WHICH ARE NEW SINCE LAST CHEMO INFUSION VISIT ON (B)(6) 2025. GIVEN NEW ACUTE KINDEY INJURY (AKI) AND CONCERN FOR HEPATORENAL SYNDROME, SHE WAS TRANSFERRED TO (B)(6) ON (B)(6) 2025. SHE RECEIVED 1 UNIT OF BLOOD, 75 G ALBUMIN 25%, WAS STARTED ON IV CEPHTRIAXONE FOR INFECTION PROTOCOL PENDING FURTHER WORK UP. WHILE ON THE ONCOLOGY MEDICINE FLOOR SHE WAS FOUND TO HAVE GRAM POSITIVE COCCI (GPC) BACTEREMIA AND URINARY TRACT INFECTION (UTI), GOT VANCOMYCIN (VANE) ((B)(6) 2025) AND CEPHALOSPORIN/ CEPHAMYCIN BETA-LACTAM ANTIBIOTIC (CTX) ((B)(6) 2025), THEN BRIEFLY SWITCHED TO OXACILLIN ((B)(6) 2025). HER AKI WAS PROGRESSIVE, AND RENAL WAS CONSULTED, WHO FELT THIS LIKELY REPRESENTED ATN (ACUTE TUBULAR NECROSIS) OVERLYING HEPATORENAL SYNDROME (HRS) PHYSIOLOGY. SHE WAS NOTED TO HAVE PANCYTOPENIA WITH PROMINENT LEUKOPENIA AND THROMBOCYTOPENIA. SHE GOT NPLATE (B)(6) 2025, GRANULOCYTE COLONY-STIMULATING FACTOR (GCF-STIM) ON (B)(6) 2025. SHE DEVELOPED WORSENING MENTAL STATUS CONCERNING FOR METABOLIC ENCEPHALOPATHY 2/2 UREMIA. SHE WAS ULTIMATELY TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) ON (B)(6) 2025 FOR INITIATION OF METABOLIC ACIDOSIS AND INITIATION OF CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) AND WAS ALSO HAVING SEVERE HYPOGLYCEMIA AND BRADYCARDIA. AFTER ARRIVING TO THE ICU STARTED ON PRESSORS FOR MULTIFACTORIAL SHOCK, AND ULTIMATELY INTUBATED FOR WORSENING MENTAL STATUS, TACHYPNEA, AND CONCERN FOR AIRWAY PROTECTION. SHE WAS SWITCHED TO VANE ((B)(6) 2025) + ZOSYN ((B)(6) 2025). PER HEPATOLOGY HAVING FULMINANT HEPATITIS, LIKELY MULTIFACTORIAL. ON (B)(6) 2025 WITH DECISION FROM THE SUBJECT'S FAMILY AND CARE TEAM, THE SUBJECT WAS TRANSITIONED TO COMFORT MEASURES ONLY AND INTERVENTIONS NOT CONTRIBUTING TO COMFORT WERE STOPPED. THE SUBJECT PASSED ON (B)(6) 2025 AT 10:15 AM WE ARE REPORTING THIS AS A GRADE 5 HEPATIC FAILURE, UNRELATED TO GEMCITABINE, UNRELATED TO CISPLATIN, UNRELATED TO DURVALUMAB, UNRELATED TO YTTRIUM-90.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2584538 CONTINUOUS RENAL REPLACEMENT THERAPY(CRRT) DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI UNK

Patients

Seq Age Sex Outcome Treatment
1 70 YR Female Death ACETYLCYSTEINE (ACETADOTE) 26.88 G IN 1200 ML.| ALBUMIN HUMAN 25% INFUSION: (B)(6) 2025.| ASCORBIC ACID (VITAMIN C) TABLET 500 MG.| CEFTRIAXONE 2G IN SODIUM CHLORIDE .9% NS, 100ML MBP EVER 24 HOURS: (B)(6) 2025.| CISPLATIN: (B)(6) 2025.| ETOMIDATE (AMIDATE) INJECTION 14 MG.| FENTANYL (PF) IN SODIUM CHLORIDE 0.9% 50 MCG/ML INFUSION, TITRATED 0-4: (B)(6) 2025.| FILGRASTIM -SNDZ (ZARXIO) INJECTION 5 MCG/KG: (B)(6) 2025.| FOLIC ACID (FOLVITE) TABLET 1 MG: (B)(6) 2025.| FUROSEMIDE (LASIX) INJECTION 40 MG.| GEMCITABINE: (B)(6) 2025.| HYDROCORTISONE SODIUM SUCCINATE (PF) (SOLU-CORTEF) INJECTION 50 MG.| HYDROMORPHONE (DILAUDID) INJECTION 0.4 MG.| LACTATED RINGERS (LR) BOLUS 1,000 ML.| LACTULOSE (ENULOSE) 10 GRAM/15 ML SOLUTION 20 G.| MORPHINE INJECTION 2 MG/ML.| MULTIVITAMIN WITH MINERALS ORAL LIQUID 15 ML.| NOREPINEPHRINE (LEVOPHED) 8 MG/250 ML (32 MCG/ML) IN D5W INFUSION: (B)(6) 2025.| OXACILLIN 1 GM IN SODIUM CHLORIDE 0.9% (NS) EVERY 4 HOURS: (B)(6) 2025.| PANTOPRAZOLE (PROTONIX) 40 MG IN SODIUM CHLORIDE 0.9% (NS_ (PF) 10 ML: (B)(6) 2025.| PHENYLEPHRINE 1000 MCG/10 ML (100 MCG/ML) IN NS (NEO-SYNEPHRINE) IV S.| PHYTONADIONE (VITAMIN K1) (AQUA-MEPHYTON) 10 MG IN SODIUM CHLORIDE 0.9: (B)(6) 2025.| PIPERACILLIN-TAZOBACTAM (ZOSYN) IVPB 2.25 G.