MAUDE Adverse Event Report: HOSPIRA PCA PUMP (HOSPIRA LIFECARE PCA)

Device Problems Accessory Incompatible (1004); Programming Issue (3014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Other  

Event Description

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).

• Brand Name: PCA PUMP (HOSPIRA LIFECARE PCA)
• Type of Device: PCA PUMP (HOSPIRA LIFECARE PCA)
• Manufacturer (Section D): HOSPIRA
• MDR Report Key: 3963481
• MDR Text Key: 17389940
• Report Number: MW5037453
• Device Sequence Number: 1
• Product Code: MEA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 06/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Patient Sequence Number: 1
• Treatment: CERNER EHR