FDA Adverse Event Malfunction Summary report: N

CURLIN

MDR report key: 3232379 · Received June 26, 2013

Report

Report Number
3232379
Event Type
Malfunction
Date Received
June 26, 2013
Date of Event
May 28, 2013
Report Date
June 26, 2013
Manufacturer
MOOG
Product Code
FRN
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CA, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

AN INFUSION OF DILAUDID 0.2 MG/ML WAS STARTED IN THE EARLY AFTERNOON. APPROXIMATELY A HALF HOUR LATER IT WAS NOTED THAT THE PATIENT'S CONDITION CHANGED (RESP. 6, O2 SATURATION 83). THE PATIENT WAS VERY HARD TO AWAKEN. THE PCA PUMP WAS STOPPED AND IT WAS NOTED THAT THE MEDICATION BAG WAS HALF GONE. PER PUMP SETTINGS NO INJECTIONS HAD BEEN GIVEN AND NO MEDICATION HAD BEEN INFUSED. THE PATIENT WAS NOT RESPONDING TO SIMPLE COMMANDS. SHE WAS CONFUSED, COMBATIVE, AND THRASHING IN BED. OXYGEN AT 8 L WAS PLACED ON THE PATIENT VIA FACE MASK. SHE WAS RESPONDING TO NOXIOUS STIMULI, AND HER HEART RATE WAS INCREASING, AND BLOOD PRESSURE WAS DECREASING. THE PATIENT'S O2 SATURATION WAS ALSO COMING BACK UP. NARCAN WAS GIVEN TO THE PATIENT APPROXIMATELY 15 MINUTES AFTER PATIENT'S CONDITION CHANGED. THE PATIENT WAS THEN AWAKING TO HER NAME, AND THEN DRIFTING OFF TO SLEEP. HER RESPIRATIONS BEGAN INCREASING AT THIS TIME. THE PCA WAS REMOVED AND SEQUESTERED. THE PATIENT HAD RECEIVED 1.6 MG IN 1 HOUR IV PUSH AND THEN 10 MG VIA PUMP IN 30 MINUTES IN ERROR FROM PUMP MALFUNCTION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
289658 CURLIN PUMP, INFUSION FRN MOOG PAINSMART IOD *

Patients

Seq Age Sex Outcome Treatment
1 56 YR