FDA Adverse Event Malfunction Summary report: N

ALARIS

MDR report key: 10188654 · Received June 24, 2020

Report

Report Number
10188654
Event Type
Malfunction
Date Received
June 24, 2020
Date of Event
April 22, 2020
Report Date
May 21, 2020
Manufacturer
CAREFUSION 303, INC.
Product Code
FRN
Product Problem
Yes
Report Source
User Facility report
Reporter Location
TX
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

A YOUNG ADULT DIABETIC, OB PATIENT PRESENTED TO L&D TRIAGE. SHE HAD BEEN NON-COMPLIANT WITH HER INSULIN REGIMEN AND HAD NOT TAKEN HER INSULIN IN 8 DAYS. ON ADMISSION: 1-HR GTT 220 MG/DL. ADMITTED TO L&D WITH ORDER FOR INSULIN DRIP. REGULAR (NOVOLIN) 250 UNITS IN SODIUM CHLORIDE 0.9 % 250 ML. ORDERED DOSE @ 0444: 0-2.5 UNITS/HR. FREQUENCY: TITRATE @ 0-2.5 ML/HR. 0615 INFUSION STARTED. 0700 PHYSICIANS CALLED TO BEDSIDE. PATIENT MISTAKENLY RECEIVED 250 UNIT(S) IV REGULAR INSULIN SECONDARY TO PUMP MALFUNCTION CAUSING INSULIN TO BE RAPIDLY ADMINISTERED. SLIGHT SHAKINESS BUT REMAINED ALERT AND ORIENTED. CBG 114. INSULIN DRIP DISCONTINUED. STAT BMP AND D50 AMPULE ADMINISTERED. D5LR AT 125 CC/HR STARTED ON NEW PUMP. BASELINE EKG AND TELEMETRY INITIATED. INITIAL GLUCOSE MONITORING: 0744: 175; 0803: 159; 0820: 140; 0848: 137; 0901: 133; 0913: 127; 0923: 125; 0947: 111; 1006: 128; 1025: 87; 1043: 111; 1104: 111 INFANT DELIVERED WITH NO SYMPTOMS OF HYPOGLYCEMIA. IMMEDIATE ACTIONS PUMP SEQUESTERED PER POLICY. DATA PULL BY CLINICAL EDUCATION WITH ASSISTANCE FROM BD. PRELIMINARY BD INVESTIGATION THE NEXT DAY: THE LOG ONLY SHOWS THAT IT ONLY RAN FOR APPROXIMATELY 46 MINUTES BEFORE IT WAS CHANNELED OFF. THERE WERE NO ALARMS PRIOR TO CHANNELING THE DEVICE OFF. THE LOG REVIEW DOES NOT SHOW ANY PROGRAMMING ISSUES. ADDITIONAL INFORMATION HAS BEEN REQUESTED BY BD AND IS BEING PROVIDED. BD COMPLAINT FAILURE INVESTIGATION REPORT. ROOT CAUSE ANALYSIS: THE ROOT CAUSE OF THE REPORTED OVER INFUSION WAS NOT IDENTIFIED. INVESTIGATION CONCLUSION: THE REPORT OF AN OVER INFUSION WAS NOT CONFIRMED. THE PCU EVENT LOG SHOWS PUMP MODULE WAS PROGRAMMED TO INFUSE INSULIN 250UNIT/250ML (DRUG ID 131) AT A RATE OF 1ML/HR WITH A VTBI OF 1ML AND RAN FOR APPROXIMATELY 46 MINUTES WHEN THE DEVICE WAS CHANNELED OFF. THE VOLUME RECORDED AS BEING INFUSED DURING THIS PERIOD WAS 0.724ML. THERE WERE NO ALARMS PRIOR TO CHANNELING THE DEVICE OFF, HOWEVER PRIOR TO STARTING THE INFUSION, THE DEVICE ALARMED FOR FLO STOP OPEN FOR 11 SECONDS. A REVIEW OF THE DEVICE ERROR LOGS FOUND NO ERRORS DURING THE TIME PERIOD OF THE REPORTED EVENT. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. AFTER A DETAILED LOOK HERE IS WHAT OUR TEAM MEMBER HAS NOTED ON THE MODULES: UPDATE FROM CLINICAL ENGINEERING: PUMP HAS A BROKEN PLATEN HINGE ASSEMBLY. THE FUNCTIONALITY OF THE PLATEN HINGE ASSEMBLY IS TO HOLD THE TUBING SET IN ITS PLACE. WHILE INFUSING, THE FLUID FLOWS FROM TOP PRESSURE SENSOR TO BOTTOM PRESSURE SENSOR. THE BROKEN ASSEMBLY WOULD HAVE COMPROMISED THE PRESSURE SENSOR THUS AFFECTING FLOW. MANUFACTURER RESPONSE FOR BD ALARIS IV INFUSION PUMP, ALARIS PUMP (PER SITE REPORTER) INVESTIGATION CONCLUSION: THE REPORT OF AN OVER INFUSION WAS NOT CONFIRMED. THE PCU EVENT LOG SHOWS PUMP MODULE WAS PROGRAMMED TO INFUSE INSULIN 250UNIT/250ML (DRUG ID 131) AT A RATE OF 1ML/HR WITH A VTBI OF 1ML AND RAN FOR APPROXIMATELY 46 MINUTES WHEN THE DEVICE WAS CHANNELED OFF. THE VOLUME RECORDED AS BEING INFUSED DURING THIS PERIOD WAS 0.724ML. THERE WERE NO ALARMS PRIOR TO CHANNELING THE DEVICE OFF, HOWEVER PRIOR TO STARTING THE INFUSION, THE DEVICE ALARMED FOR FLO STOP OPEN FOR 11 SECONDS. A REVIEW OF THE DEVICE ERROR LOGS FOUND NO ERRORS DURING THE TIME PERIOD OF THE REPORTED EVENT. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
652867 ALARIS PUMP, INFUSION FRN CAREFUSION 303, INC.

Patients

Seq Age Sex Outcome Treatment
1 8760 DA