FDA Adverse Event Other Summary report: N

DIALYSATE SOLUTION

MDR report key: 18436732 · Received January 2, 2024

Report

Report Number
MW5149726
Event Type
Other
Date Received
January 2, 2024
Report Date
October 24, 2023
Manufacturer
MEDIVATORS INC.
Product Code
KDI
Report Source
Voluntary report
Reporter Occupation
UNKNOWN
Health Professional
*

Narratives

Description of Event or Problem · 0

AN EVENT OCCURRED RELATED TO HEMODIALYSIS TREATMENT OF THE INCORRECT PATIENT IN A LARGE ACADEMIC INPATIENT FACILITY. THE 5 RIGHTS WERE NOT VERIFIED BY THE DIALYSIS NURSE OR BEDSIDE NURSE PRIOR TO INITIATING TREATMENT. THESE EVENTS LED TO THE WRONG PATIENT RECEIVING DIALYSIS FOR APPROXIMATELY 10 MINUTES AND THE PATIENT WHO NEEDED THE TREATMENT EMERGENTLY HAD A DELAY IN CARE. PROCESS IN PLACE AT THE TIME OF EVENT WAS FOR THE DIALYSIS NURSE TO MANUALLY VERIFY THE 5 RIGHTS PRIOR TO INITIATING THE TREATMENT. THERE WAS NOT ANYWHERE TO DOCUMENT THIS, IT WAS ONLY ASSUMED THIS WAS BEING COMPLETED WITH EVERY PATIENT, EVERY TIME. IN ADDITION, THE DIALYSIS BATHING SOLUTION ARE HAND MIXED BASED OFF OF THE PRESCRIBERS ORDERS. THIS COULD MEAN THE DIALYSIS NURSE IS ADDING MULTIPLE PACKETS OF POTASSIUM, PHOSPHORUS, ETC. TO THE BATHING SOLUTIONS WITHOUT ANY VERIFICATION THE CORRECT AMOUNT WAS ADDED. THE ABILITY TO SCAN THE DIALYSATE SOLUTION AND ELECTROLYTE ADDITIVES DOES NOT EXIST. THE MANUFACTURER (MEDIVATORS, INC.) OF THE ELECTROLYTE ADDITIVES AND THE BATHING SOLUTIONS DOES NOT PROVIDE A BARCODE TO FACILITATE THE RISK REDUCTION STRATEGIES USED FOR ALL OTHER MEDICATION ADMINISTRATIONS IN INPATIENT HEALTHCARE FACILITIES. EPIC IS OUR CURRENT EHR PROVIDER. ISMP, 5200 BUTLER PIKE, PLYMOUTH MEETING, PA 19462, PHONE: 215-947-7797, EMAIL: [email protected]. SUBMISSION ID: 87998.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1699616 DIALYSATE SOLUTION DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI MEDIVATORS INC.

Patients

Seq Age Sex Outcome Treatment
1 Unknown EPIC EHR.