FDA Adverse Event Malfunction Summary report: N

ALARIS PCA MODULE

MDR report key: 5999637 · Received October 5, 2016

Report

Report Number
5999637
Event Type
Malfunction
Date Received
October 5, 2016
Date of Event
July 20, 2016
Report Date
August 17, 2016
Manufacturer
CAREFUSION 303, INC.
Product Code
MEA
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CA, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

PCA PUMP CONTINOUS INFUSION WITH FENTANYL 50MCG/ML 55ML MONOJECT SYRINGE BY (B)(6), ALARMING OCCLUSION. PUMP CHANGED, TUBING CHANGED,AND FENTANYL SYRINGE PUMP CHANGED. PCA PUMP RESTARTED AND CONTINUED ALARMING OCCLUSION. SYRINGE REMOVED AND DREW BACK AIR THEN PRIMED FENTANYL TO TIP OF SYRINGE AND RELOADED, RESTARTED, AND PCA FENTANYL WOULD INFUSE FOR 3-4 HOURS AND ALARM OCCLUSION. HOSPITAL FACILITY'S BIOMEDICAL ENGINEERING INVESTIGATION INITIATED. THE ENTIRE INFUSION PUMP, SYRINGE AND PATIENT TUBING SET WAS TESTED FOR OCCLUSION ALARMS AND AFTER 3.5 HRS, PCA PUMP STARTED TO ALARM "OCCLUSION". SEVERAL ATTEMPTS WERE MADE TO RESTART THE PCA PUMP, THE PUMP WOULD ALARM IN A SHORT PERIOD OF TIME. THE PCA PUMP WAS STOPPED, THE SYRINGE REMOVED AND THE TUBING REMOVED FROM THE SYRINGE. THE TUBING WAS TESTED FOR ANY FLOW OBSTRUCTIONS AND THERE WERE NONE. WHEN THE SYRINGE WAS TESTED WITHOUT THE PATIENT TUBING ATTACHED, IT WAS DIFFICULT TO PUSH THE PLUNGER TO THE POINT THAT IT WOULD REQUIRE EXCESSIVE FORCE TO DRIVE THE PLUNGER DOWN THE BARREL OF THE SYRINGE AND THE LEVEL OF FORCE WAS NEVER ACHIEVED. THE SYRINGE BY (B)(6) IS A MONOJECT 60CC. HOSPITAL TESTING CONFIRMED THERE IS AN ISSUE WITH THIS PARTICULAR BRAND OF SYRINGE. HOSPITAL FACILITY WAITING FOLLOW UP FROM (B)(6) TO DETERMINE FURTHER INVESTIGATION WITH SYRINGES DUE TO CONCERN THAT PATIENTS REQUIRING PAIN MEDICATION ARE NOT RECEIVING THE APPROPRIATE AMOUNT OF MEDICATIONS AND RISK IF THE SYRINGE PLUNGER WERE TO BREAK LOOSE, RISK OF BOLUS GIVEN TO PATIENT. FENTANYL 50MCG/ML MONOJECT SYRINGE ITEM #2K8673, NDC (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
653290 ALARIS PCA MODULE PUMP, INFUSION MEA CAREFUSION 303, INC. UKN UKN

Patients

Seq Age Sex Outcome Treatment
1