FDA Adverse Event Injury Summary report: N

ALARIS IV PUMP

MDR report key: 18885069 · Received March 8, 2024

Report

Report Number
MW5152606
Event Type
Injury
Date Received
March 8, 2024
Date of Event
February 25, 2024
Report Date
March 6, 2024
Manufacturer
CAREFUSION 303, INC.
Product Code
FRN
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
RISK MANAGER
Health Professional
Yes

Narratives

Description of Event or Problem · 0

INFANT BORN TO A 35 YO (YEAR-OLD), G2P1 (GRAVIDA 2, PARA 1). 37.2 GA (37.2 WEEKS GESTATIONAL AGE). GBR NEGATIVE. C/S (CAESAREAN) DELIVERY. APGARS 8/9. BIRTH WT (WEIGHT): 2377G. AT 2 HOURS OF AGE, ADMITTED DUE TO RESPIRATORY DISTRESS. AT 0052, INITIAL BLOOD GLUCOSE 35. AT 0057, 1.5ML ORAL GLUCOSE GEL GIVEN. AT 0100, 7ML SIMILAC BOTTLE FED, AND REPEAT AT 0220 BLOOD GLUCOSE 61. RECHECKED APPROPRIATELY PER PROTOCOL. AT 0225, TFL 60ML/KG/D WITH D10 IVF (DEXTROSE 10% SOLUTION, INTRAVENOUS FLUIDS). ADVANCE FEEDS BY 15ML/KG Q (EVERY) SHIFT TO GOAL OF 160ML/KG/D AND TITRATE IVF. SEPSIS WORK UP COMPLETED UPON ADMISSION TO NICU (NEONATAL INTENSIVE CARE UNIT). AT 0225, D10 INITIATED AT 5.9ML/HR. AT 0515, GLUCOSE >600. D10 STOPPED AT THIS TIME. MD (PHYSICIAN) IMMEDIATELY NOTIFIED. THAT 250ML OF D10 WAS INFUSED. ORDERS RECEIVED TO RECHECK BLOOD GLUCOSE IN 1 HOUR. AT 0530, INSULIN ORDERED AND ORDER FOR RECHECK 30 MINUTES AFTER ADMINISTERED INSULIN THEN Q 1 HOUR CHECKS. AT 0619, GLUCOSE >600, 0.02 REGULAR INSULIN GIVEN AT AUDIT REPORT SHOWS PUMP WAS PROGRAMED AT 5.9 ML/HR WITH VTBI (VOLUME TO BE INFUSED) 5.9ML. TOTAL VOLUME PER PUMP THAT WAS INFUSED WAS 13.7ML, HOWEVER ENTIRE BAG OF 250ML HAD BEEN TRANSFUSED. TERM INFANT, ADMITTED TO NICU FOR RESPIRATORY DISTRESS AND HYPOGLYCEMIA.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
181220 ALARIS IV PUMP PUMP, INFUSION FRN CAREFUSION 303, INC. 8015

Patients

Seq Age Sex Outcome Treatment
1 1 DA Male Required Intervention