FDA Adverse Event Malfunction Summary report: N

AQUAFLEXFLOW UF 500 PLUS

MDR report key: 12697546 · Received October 26, 2021

Report

Report Number
12697546
Event Type
Malfunction
Date Received
October 26, 2021
Date of Event
October 19, 2021
Report Date
October 22, 2021
Manufacturer
CHF SOLUTIONS INC
Product Code
KDI
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CA
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

PINK TINGED EFFLUENT NOTED IN EFFLUENT BAG IMMEDIATELY UPON TREATMENT INITIATION. PAGE SENT TO FELLOW, TEAM CARING FOR PATIENT (PT) TODAY WAS UNAWARE OF ANY PREVIOUS EVENTS RESULTING IN QUESTIONABLE BLOOD LEAK. FELLOW DISCUSSED WITH ATTENDING AND DECIDED WE SHOULD TERMINATE TREATMENT. CARTRIDGE WAS SAVED TO BE SENT TO MANUFACTURER FOR FURTHER INVESTIGATION. UPON FURTHER DISCUSSION WITH AQUAPHERESIS REP., THIS WAS AN ISSUE THOUGHT TO HAVE HAPPENED ON WEDNESDAY. NO NOTES/ ICARES RELAYED TO THE TEAM REGARDING THIS ISSUE. SEVERAL HD (HEMODIALYSIS) NURSES WERE "WATCHING" THIS PATIENT DUE TO SHORT STAFFING. IMPROVED COMMUNICATION REGARDING HAND OFF AND EVENTS. PER DIALYSIS NURSE, PINK TINGED IN EFFLUENT BAG RIGHT AFTER INITIATION. PCM (PATIENT CARE MANAGER) WERE NOT AWARE THAT THIS HAPPENED LAST WEEK WITH THE SAME ISSUE. UNSURE RATHER IT WAS THE SAME LOT # AS IT WAS ALREADY DISCARDED. SALES REP. FOR AQUADEX WAS NOTIFIED OF THE ISSUE. CARTRIDGE WAS SAVED FOR FURTHER INVESTIGATION. NEPHROLOGY FELLOW AND ATTENDING WERE NOTIFIED AND AGREED TO RE-START A NEW SET-UP WITH BLOOD PRIME. PCM TO DISCUSS THIS IN HUDDLES OF BETTER COMMUNICATIONS TO PROVIDE BETTER CARE AND QUALITY TO OUR PATIENTS. PCM SPOKE TO MEDICAL DIRECTOR. SHE BELIEVED IT IS HEMOLYSIS FROM THE PATIENT AND NOT THE MACHINE OR THE CARTRIDGE. WE WILL START WITH A SLOW BFR (BLOOD FLOW RATE) AND GRADUALLY INCREASE TO PRESCRIBED BFR, PERHAPS THIS WILL HELP. DISCUSSED THE PLAN WITH THE TEAM TO IMPLEMENT AND TRACK IF IT HELPS. THERE WAS NO HARM IN THIS EVENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1597169 AQUAFLEXFLOW UF 500 PLUS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI CHF SOLUTIONS INC 114156 21168

Patients

Seq Age Sex Outcome Treatment
1 12 DA