FDA Adverse Event Malfunction Summary report: N

ALARIS 8100 INFUSION PUMP

MDR report key: 1217863 · Received October 30, 2008

Report

Report Number
1217863
Event Type
Malfunction
Date Received
October 30, 2008
Date of Event
August 16, 2008
Report Date
October 29, 2008
Manufacturer
CARDINAL HEALTH MEDICAL PRODUCTS & SERVICES
Product Code
FRN
Product Problem
Yes
Report Source
User Facility report
Reporter Location
AZ, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

A PATIENT WAS IN THE ED FOR CHEST PAIN AND WAS ON A HEPARIN DRIP. THE PUMP SETTINGS WERE CHECKED BY THE NURSE AT THE BEGINNING OF THE MORNING SHIFT WHICH SHOWED SETTINGS OF HEPARIN INFUSING AT 17ML/HR, 18MCG/KG/HR, WHICH WAS THE APPROPRIATE DOSE. APPROXIMATELY 2.5 HOURS LATER, THE PATIENT'S 6 HOUR REPEAT PTT RESULTS WERE >150, WHICH WAS UP FROM THE INITIAL VALUE OF 28. THE PUMP SETTINGS INDICATED NO CHANGES AT THAT TIME. THE DOCTOR WAS NOTIFIED OF THE LAB RESULTS, AND THERE WAS NO ORDER TO CHANGE THE DOSE OR THE INFUSION RATE OF THE HEPARIN. APPROXIMATELY 1.5 HOURS AFTER THE PTT RESULTS WERE RECEIVED, THE HEPARIN BAG APPEARED TO BE ABNORMALLY EMPTY TO THE NURSE. THE PUMP WAS CHECKED BY THE NURSE, AND THERE WERE NO CHANGES IN THE SETTINGS. HOWEVER, WHEN THE NURSE CHECKED THE TOTAL VOLUME INFUSED, THE PUMP STATED 216.57ML. THE TOTAL VOLUME INFUSED INDICATED AN INFUSION RATE OF APPROXIMATELY 24ML/HR. A SECOND NURSE CHECKED THE PUMP DISPLAY AND VERIFIED THE CALCULATION DISCREPANCY. THE PUMP WAS REMOVED FROM SERVICE. THE PATIENT WAS SCHEDULED FOR A PROCEDURE LATER THAT AFTERNOON. THE DOCTOR WAS NOTIFIED OF THE ISSUE AND THERE WAS NO CHANGE TO THE PATIENT'S TREATMENT PLAN. THERE WAS NO PATIENT HARM.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ALARIS 8100 INFUSION PUMP INFUSION PUMP FRN CARDINAL HEALTH MEDICAL PRODUCTS & SERVICES 8100, 8015 *

Patients

Seq Age Sex Outcome Treatment
1 * NO OTHER THERAPIES| NO OTHER THERAPIES