MAUDE Adverse Event Report: HOSPIRA COSTA RICA LTD. LIFECARE PCA 3 V5.06; 80MEA

Catalog Number 20709

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

Patient Problems Cardiopulmonary Arrest (1765); Brain Injury (2219)

Event Date 12/17/2013

Event Type  Injury  

Event Description

The customer contact reported an adverse event while the device was in use.At 1549, the post anesthesia care unit (pacu), the device was programmed to deliver morphine 1mg/ml, in the pca only mode, with a 1mg pca dose, a 10 minute patient lock out and no dose limit.At 1749, it was reported that the patient was transferred to surgical floor.At 1755, it was reported that the pca dose was increased to 2mg.At 2029, it was reported that the patient was sitting up and talking.At 2151, it was reported the nurse found the patient lying on his side, unresponsive, and had no pulse.At that time, a code blue was called and cardiopulmonary resuscitation was initiated and the patient was resuscitated.No specific event details were provided.At 2159, it was reported that the patient was transferred to the surgical intensive care unit (sicu) and was on hypothermia protocol for 24 hours.The customer contact reported that the patient suffered a unrecoverable brain injury.The customer contact reported the device did not contribute to the patient event and there was no device malfunction.During testing at the user facility, the device passed testing for delivery accuracy.Though requested, no additional information was provided.

Manufacturer Narrative

Investigation is not complete.The device history was downloaded at the user facility.A review of the history indicates that on (b)(6) 2013 between 1514 and 1751, the device was powered on, history cleared, morphine 1mg/ml was confirmed, cca medical surgical was selected, the device was programmed in the pca only mode, with a loading dose of 1mg, a 1mg pca dose, a 10 minute pca lockout, with no dose limit, settings were confirmed, door was locked once, there were twelve 1mg pt initiated deliveries, and 30 unmet demands.Between 1755 and 2132, door was opened once, pca dose was changed to 2.0mg, pca dose was confirmed, door was locked once, there were 32 unmet pt demands, six 2.0mg pt initiated deliveries, 2 low battery alarms, door was opened and the device was powered off.On (b)(6) 2013 between 1046 and 1049, there was a new day stamp, and 24.0 mg totals cleared.A review of the history indicates that the device delivered as programmed.This report represents all the information known by the reporter upon query by hospira personnel.

• Brand Name: LIFECARE PCA 3 V5.06
• 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 dr.; bldg. no. h2-1east, dept no. 097u; lake forest, IL 60045 ; 2242125740
• MDR Report Key: 3591371
• MDR Text Key: 4143402
• Report Number: 9615050-2014-00308
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2013

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 20709
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2013
• Initial Date FDA Received: 01/15/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2006
• 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: MORPHINE: MANUFACTURER UNK
• Patient Age: 37 YR