FDA Adverse Event Malfunction Summary report: N

SAPPHIRE INFUSION PUMP

MDR report key: 8089132 · Received November 20, 2018

Report

Report Number
8089132
Event Type
Malfunction
Date Received
November 20, 2018
Date of Event
October 24, 2018
Report Date
October 31, 2018
Manufacturer
Q CORE MEDICAL LTD
Product Code
FRN
Product Problem
Yes
Report Source
User Facility report
Reporter Location
FL
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

THIS ELDERLY MALE WAS IN THE POST-ANESTHESIA CARE UNIT (PACU) FOLLOWING A ROTATOR CUFF ARTHROPLASTY PROCEDURE OF THE LEFT SHOULDER. HE WAS RECEIVING ROPIVACAINE VIA A QCORE SAPPHIRE PUMP. THE ORDER WAS WRITTEN FOR NS 0.9% 200ML +ROPIVACAINE IV ADDITIVE, 400 MG, FOR PERIPHERAL NERVE INFILTRATION-TOTAL VOLUME 200ML TO INFUSE OVER 25 HOURS. THE MEDICATION WAS INFUSING VIA A LEFT NECK CENTRAL LINE IN ACCORDANCE WITH THE PHYSICIAN'S POST OP ORDER. ACCORDING TO THE PACU REGISTERED NURSE (RN), PRIOR TO TRANSFER FROM THE PACU TO THE FLOOR, THE PUMP BEGAN TO ALARM WITH A "KEY JAMMED" ERROR MESSAGE DISPLAYED. THE PUMP WAS UNPLUGGED FOR TRANSFER TO THE FLOOR AND THE ALARMING STOPPED. UPON ARRIVAL TO THE PATIENT'S ROOM THE PUMP WAS PLUGGED IN AND AGAIN BEGAN TO ALARM. UPON CHECKING THE PATIENT SETTINGS, IT WAS OBSERVED BY THE RN THAT A PATIENT BOLUS DOSE OF 5ML HAD BEEN ADMINISTERED WITHOUT THE NURSE OR THE PATIENT INITIATING A BOLUS BY PUSHING THE PCA BUTTON. THE DEVICE WAS CHANGED OUT AND SEQUESTERED BY BIO-ENGINEERING FOR EVALUATION. BIO-ENGINEERING RAN A KEY PUNCH AUDIT WHICH REVEALED THE PUMP WAS STOPPED AND STARTED. BIO-ENGINEERING SPOKE WITH QCORE WHO STATED THAT THE ERROR COULD BE ATTRIBUTED TO EITHER 1) IMPROPER PLACEMENT IN THE CRADLE ATTACHED TO THE IV POLE OR 2) AN LED DISPLAY ISSUE. BIOENGINEERING PERFORMED DIAGNOSTIC TESTING OF THE PUMP. THE PUMP WAS RUN FOR HOURS, HOWEVER THEY WERE NOT ABLE TO DUPLICATE THE STUCK ERROR. THE PUMP WAS CHECKED FOR PUMP OPERATION AND BOLUS WITH NO ERRORS. THE PUMP EVENT LOG WAS PRINTED AND REVIEWED AND FOUND THE ERRORS SILENCED AND CONFIRMED THE PUMP WAS STARTED AND THE PRESET 5 ML DEMAND BOLUS WAS PRESSED. PUMP HAS BEEN SHIPPED TO QCORE MEDICAL FOR FURTHER DIAGNOSTIC TESTING. MANUFACTURER RESPONSE FOR PCA EPIDURAL/NERVE BLOCK PUMP, SAPPHIRE PUMP (PER SITE REPORTER). BIO-ENGINEERING MANAGER CONTACTED Q CORE TO DISCUSS THE EVENT. AT THIS TIME THE PUMP WILL MOST LIKELY BE SENT BACK TO Q CORE FOR EVALUATION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
927867 SAPPHIRE INFUSION PUMP PUMP, INFUSION FRN Q CORE MEDICAL LTD 15032-000-0001

Patients

Seq Age Sex Outcome Treatment
1 29930 DA