FDA Adverse Event Other Summary report: N

PCA PUMP (HOSPIRA LIFECARE PCA)

MDR report key: 3963481 · Received July 24, 2014

Report

Report Number
MW5037453
Event Type
Other
Date Received
July 24, 2014
Report Date
June 19, 2014
Manufacturer
HOSPIRA
Product Code
MEA
Report Source
Voluntary report
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

OUR CERNER EHR IMPLEMENTATION REQUIRES (FORCED FIELD) A DEMAND DOSE LOCKOUT, A ONE-HOUR LIMIT AND A 4-HR LIMIT ON OUR PCA ORDERS. OUR PCA PUMP (HOSPIRA LIFECARE PCA) DOES NOT ALLOW PROGRAMMING OF BOTH, THE 1 HR AND THE 4 HR LIMITS (ONE OR THE OTHER IS ALLOWED). THIS PUTS US IN A POSITION OF HAVING TO CARRY OUT A PHYSICIAN ORDER THAT WE CANNOT CARRY OUT USING THE TECHNOLOGY WE CURRENTLY HAVE. ON A BOARDER SCALE, IF A PHYSICIAN ORDERS A DEMAND DOSE LOCKOUT (6-10 MIN) AND A 4 HR MG LIMIT FOR A PARTICULAR PT, THERE IS A RISK OF THE PT FRONT - LOADING ALL ALLOWED DEMAND DOSES TO THE FRONT END OF THE 4 HR WINDOW. THIS HAS THE RISK OF PHARMACOLOGICAL OVERSEDATION EARLY IN THE WINDOW, AND INADEQUATE PAIN CONTROL IN LATER PART OF 4 HR WINDOW. WE THINK IT IS GOOD TO HAVE BOTH, A 1 HR WINDOW AND A 4 HR LIMIT PROGRAMMABLE. WE THINK THAT BOTH 1 HR AND 4 HR LIMITS SHOULD HAVE MAXIMUMS WHICH ARE LESS THAN SIMPLE MULTIPLES OF THE Q6-10MINS DEMAND DOSE. WE FEEL THAT THE PCA PUMP SHOULD HAVE THE ABILITY TO LIMIT THE DOSES ON ALL THREE PARAMETERS. DEMAND DOSE LOCKOUT, 1 HR MAXIMUM AND 4 HOURS MAXIMUM. WHERE DID THE ERROR OCCUR: HOSPITAL. REPORTER'S RECOMMENDATIONS: WE THINK IT IS GOOD TO HAVE BOTH, A 1 HR WINDOW AND A 4 HR LIMIT PROGRAMMABLE. WE THINK THAT BOTH 1 HR AND 4 HR LIMITS SHOULD HAVE MAXIMUMS WHICH ARE LESS THAN SIMPLE MULTIPLES OF THE Q6-10MINS DEMAND DOSE. WE FEEL THAT THE PCA PUMP SHOULD HAVE THE ABILITY TO LIMIT THE DOSES ON ALL THREE PARAMETERS. DEMAND DOSE LOCKOUT, 1 HR MAXIMUM AND 4 HOURS MAXIMUM. (B)(6).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
434858 PCA PUMP (HOSPIRA LIFECARE PCA) PCA PUMP (HOSPIRA LIFECARE PCA) MEA HOSPIRA

Patients

Seq Age Sex Outcome Treatment
1 CERNER EHR