FDA Adverse Event Injury Summary report: N

DIALYSATE SACK WITH CONCENTRATE (SAK-302)

MDR report key: 16505279 · Received March 7, 2023

Report

Report Number
MW5115559
Event Type
Injury
Date Received
March 7, 2023
Date of Event
February 15, 2023
Report Date
March 6, 2023
Manufacturer
NXSTAGE MEDICAL, INC.
Product Code
KPO
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
LA, US
Reporter Occupation
NURSE
Health Professional
Yes

Narratives

Description of Event or Problem · 0

DESCRIBE EVENT, PROBLEM, OR PRODUCT USE ERROR: THIS WAS THE PATIENT'S FIRST AND ONLY EXPOSURE TO NXSTAGE HEMODIALYSIS. PATIENT HAD PREVIOUSLY RECEIVED A REGULAR COURSE OF DIALYSIS ON FRESENIUS 2008T DIALYSIS SYSTEM. WITHIN ONE MINUTE OF STARTING DIALYSIS, PATIENT REPORTED "MY BACK ITCHES". THE NURSE ENDED DIALYSIS TREATMENT AFTER 3 MINUTES FOR SIGNIFICANT REDUCTION IN BLOOD PRESSURE. PATIENT INITIALLY ANSWERED NEGATIVE FOR SYMPTOMS OF HYPOTENSION "I FEEL FINE EXCEPT FOR THE ITCHING". AFTER DIALYSIS TERMINATION WAS COMPLETE, PATIENT REPORTED DIZZINESS, AND DEVELOPED HIVES. IN APPROXIMATELY 5 MINUTES, THE PATIENT HAD IMPROVED TO NORMAL BLOOD PRESSURE, WITH RESIDUAL DIZZINESS AND HIVES HAD FADED. LAB SPECIMENS COLLECTED WERE NOT TO DIAGNOSE A CONDITION OR MONITOR TREATMENT, BUT RATHER ASSESS THE DIALYSIS FOR CONTAMINANTS AND ORGANISMS. ALL PRE-TREATMENT TESTS AND CHECKS OF THE DIALYSIS FORMULA (AUTOMATIC CONDUCTIVITY TEST IN RANGE & CHLORINE/CHLORAMINE LEVELS ZERO) AND CIRCUIT PRESSURES PASSED. POST-INCIDENT LAB SPECIMENS WERE COLLECTED FROM THE DIALYSIS PURIFICATION SYSTEM AND FINAL DIALYSIS FORMULA THAT THE PATIENT WAS EXPOSED TO. ALL LAB RESULTS WERE IN ACCEPTABLE RANGES FOR ELECTROLYTES, COLONY COUNT, AND ENDOTOXIN. PATIENT HAD NO KNOWN ALLERGIES PRIOR TO THIS INCIDENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
140247 DIALYSATE SACK WITH CONCENTRATE (SAK-302) DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO NXSTAGE MEDICAL, INC. 11279186

Patients

Seq Age Sex Outcome Treatment
1 69 YR Male