FDA Adverse Event Summary report: N

COLORVISION

MDR report key: 3426683 · Received October 8, 2013

Report

Report Number
3426683
Date Received
October 8, 2013
Date of Event
October 7, 2013
Report Date
October 8, 2013
Manufacturer
CAESAREA MEDICAL ELECTRONICS LTD
Product Code
FRN
Report Source
User Facility report
Reporter Location
WV, US

Narratives

Description of Event or Problem · 1

PATIENT'S MORPHINE (1MG/ML) PCA PRESCRIPTION WAS INTERRUPTED WHEN THE PUMP ALARMED FOR AIR-IN-LINE. IN ORDER TO PURGE THE AIR, THE NURSE TURNED OFF THE PUMP, THEN RESTARTED IT, WHICH IS NECESSARY TO GAIN ACCESS TO THE PRIMING FUNCTION. AFTER SUCCESSFULLY RE-PRIMING THE TUBING, THE NURSE CHOSE "SELECT PROTOCOL" AS PROMPTED BY THE PUMP, AND THEN CHOSE THE SAME PROTOCOL AS WAS PREVIOUSLY IN USE. EVEN THOUGH SHE INDICATED TO THE PUMP THAT THIS WAS NOT A NEW PATIENT, THE PUMP REVERTED TO ITS DEFAULT VALUES FOR THE SELECTED PROTOCOL WHICH WERE DIFFERENT FROM THE SETTINGS ACTUALLY IN USE.IT WAS CONFIRMED THAT THIS IS PROPER BEHAVIOR FOR THE PUMP, AND NURSES ARE CONCERNED THAT IT PUTS THE PATIENT AT RISK OF INCORRECT INFUSION IF THEY DO NOT NOTICE THAT DEFAULT VALUES ARE SET INSTEAD OF THE PREVIOUS VALUES. LATER IT WAS DISCOVERED THAT INSTEAD OF SELECTING THE DRUG PROTOCOL WHEN PROMPTED BY THE PUMP, THERE IS ALSO THE OPTION TO EXIT THE MENU WITHOUT MAKING A SELECTION. THIS BRINGS THE USER BACK TO THE ORIGINAL DRUG PROTOCOL WITH THE SAME SETTINGS AS WERE PREVIOUSLY IN USE, AND GIVES THE OPTION TO RESUME THE INFUSION.THE PUMP'S MENU DISPLAY DOES NOT PRESENT THE OPTION TO EXIT INSTEAD OF SELECTING A DRUG PROTOCOL, NOR IS IT EXPLICIT IN THE PUMP'S OPERATOR'S MANUAL, ALTHOUGH THE MANUAL DOES INCLUDE A STATEMENT THAT THE "STOP" BUTTON CAN BE USED TO EXIT FROM A PUMP MENU.THIS PROBLEM PRIMARILY OCCURS WHEN AN EXISTING INFUSION IS INTERRUPTED THEN RESTARTED. OTHERWISE THE PROTOCOL HAS COMPLETED AND THERE IS NO NEED TO RESTART WITH PREVIOUS SETTINGS.MANUFACTURER RESPONSE, PER REPORTER: MANUFACTURER ACCEPTED COMMENTS FOR CONSIDERATION AND POSSIBLE REVISION OF USER MANUAL OR PUMP OPERATION, AS NEEDED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
510281 COLORVISION PUMP, INFUSION, PAIN CONTROL FRN CAESAREA MEDICAL ELECTRONICS LTD 575 *

Patients

Seq Age Sex Outcome Treatment
1 *