MAUDE Adverse Event Report: HOSPIRA COSTA RICA LTD LC PCA III INFUSER; 80MEA

Catalog Number 12384

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Lethargy (2560)

Event Date 05/01/2014

Event Type  Injury  

Event Description

The customer contact reported an adverse event while the device was in clinical use.It was reported that the pt was diagnosed with primary malignant neoplasm of the descending colon and was status postoperative for an unspecified procedure.On (b)(6) 2014 at an unspecified time, the device was programmed to deliver hydromorphone 1 mg/1 ml, in the pca and continuous mode, with a continuous rate of.05 mg/hr, a pca dose of 0.7 mg, a 10 minute pt lock out, with no dose limit, and the delivery was started.On (b)(6) 2014 at an unspecified time during the night, it was reported the nurse noted that the pt was nonverbal and had snoring respirations.At that time, an unspecified concentration of narcan was delivered to the pt.The customer contact reported the pt was transported to the intensive care unit, a narcan drip was initiated and blood gases were drawn.No results were provided.No specific programming parameters were provided.It was reported after an unspecified length of time, the pt was responsive.The customer contact reported that the pt's wife informed the nurse that she had pressed the pca pt pendant button 24 times while the pt was asleep to ensure the pt was not in pain.It was reported the nurse noted that 14 out of 24 pt demands had been delivered.The customer contact reported the wire was verbally educated that the pt pendant is only to be pressed by the pt.On an unspecified date, the customer contact reported the pt was transported to a different care facility.Though requested, no additional info has been provided.

Manufacturer Narrative

The device passed testing.Based on the data verified, hospira could not attribute the issue to the device.The device history was downloaded at the service center.A review of the history indicates that on (b)(6) 2014 at 1044, the device was programmed and confirmed to deliver in the pca + continuous mode, a drug concentration of 1 mg/ml, with a 0.7mg pca dose, a 10 minute pca lockout, a 0.5 mg continuous rate with no dose limit selected, the door was locked and the infusion was started.Between 1045 and 0647, there were 25, 0.7 mg pt initiated pca deliveries and 27 unmet demands.At 0000, there was new day stamp of (b)(6) 2014.At 0658, the device alarmed for an empty syringe alarm and a pca stop dose of 0.3 mg was delivered.Between 0704 and 0705, the door was opened, there was 1 check vial alarm, 1 check syringe alarm, 1 check injector alarm, confirmed and continued custom vial with same programming, the door was locked, and the infusion was started.Between 0709 and 0903, there were 10, 0.7mg pt initiated pca deliveries and 6 unmet demands.Between 0942 and 1202, the device had 6 infuser paused alarms, the door was opened 4 times, there were 4 door opened alarms, 2 check printer alarm, 4 door locked alarms, and 2 start infusion alarms.At 1207, the door was opened, the device alarmed for check vial, check syringe, and the device was powered off.Review of the history indicates the device delivered as programmed.This report represents all the info known by the reporter upon query by hospira personnel.

• Brand Name: LC PCA III INFUSER
• Type of Device: 80MEA
• Manufacturer (Section D): HOSPIRA COSTA RICA LTD; zona franca global; la aurora heredia ; CS
• Manufacturer (Section G): HOSPIRA COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: juergen schmider, md, vp ; 275 n field drive; bldg no. h2-1east, dept no 097u; lake forest, IL 60045 ; 2242125740
• MDR Report Key: 3875999
• MDR Text Key: 4461507
• Report Number: 9615050-2014-03758
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043256
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 12384
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/19/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2014
• Initial Date FDA Received: 05/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: HYDROMORPHONE, MFG BY HOSPIRA INC.
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 58 YR