FDA Adverse Event Malfunction Summary report: N

LIFECARE INFUSION SYSTEM

MDR report key: 1780508 · Received July 27, 2010

Report

Report Number
1780508
Event Type
Malfunction
Date Received
July 27, 2010
Date of Event
July 15, 2010
Report Date
July 23, 2010
Manufacturer
HOSPIRA INC
Product Code
MEA
Product Problem
Yes
Report Source
User Facility report
Reporter Location
NC, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

WHEN THE NURSES HAVE TO GIVE A MED THAT IS NOT COMPATIBLE WITH THE PCA MED, THEY CLAMP THAT MED FOR THE DURATION OF THE OTHER INFUSION AND THEN, WHEN THE INFUSION IS COMPLETED, THEY RELEASE THE CLAMP AND RESTART THE PCA INFUSION. THE NURSES USUALLY USE THE PCA TUBING CLAMP (SLIDE CLAMP), WHICH IS A SMALL WHITE CLAMP ON THE TUBING. THIS IS NOT EASILY SEEN AND CAN BE MISSED OR FORGOTTEN. THIS IS A PATIENT WHO HAS MULTIPLE IV MEDS AND ONLY LIMITED IV ACCESS. THE PATIENT HAD MORPHINE PCA INFUSING. THE PCA TUBING WAS CLAMPED IN ORDER TO GIVE ANOTHER MEDICATION, AND THE CLAMP WAS NOT REMOVED WHEN THE INFUSION OF THE OTHER MEDICATION WAS COMPLETE. THEREFORE, THE PATIENT WENT WITHOUT PAIN MEDICATIONS FOR ABOUT 2 HOURS. THE PUMP DID NOT ALARM TO ALERT RN OF A DISTAL OCCLUSION. WHEN IT WAS DISCOVERED, THE RN DISCONNECTED THE PCA TUBING FROM PATIENT BEFORE SHE UNCLAMPED THE TUBING, AND A SIGNIFICANT AMOUNT OF MORPHINE CAME SHOOTING OUT. HAD THIS BEEN CONNECTED TO THE PATIENT, THE PATIENT WOULD HAVE BEEN BOLUSED WITH AN UNKNOWN AMOUNT OF PAIN MEDICATION. THE PCA WAS TO BE INFUSING AT A RATE OF 1.5 ML PER HOUR, SO IT IS NOT CLEAR WHY THE PUMP DID NOT ALARM. BOTH THE FAILURE TO RECOGNIZE THAT THE TUBING IS STILL CLAMPED AS WELL AS THE ALARM FAILURE HAVE OCCURRED MULTIPLE TIMES ON MORE THAN ONE PUMP. THE NURSING STAFF IS GOING TO SWITCH TO USING BRIGHT BLUE HEMOSTATS TO CLAMP THE LINES. HOSPIRA HAS BEEN NOTIFIED OF THE ALARM ISSUE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 LIFECARE INFUSION SYSTEM PCA PUMP MEA HOSPIRA INC * *
2 * PCA SET WITH INJECTOR, MINI-BORE FPA HOSPIRA * *

Patients

Seq Age Sex Outcome Treatment
1 14 MO