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

Catalog Number 20709

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Apnea (1720); Bradycardia (1751); Oversedation (1990); Loss of consciousness (2418); Low Oxygen Saturation (2477)

Event Date 05/23/2015

Event Type  Injury  

Event Description

The customer contact reported the patient received more medication than intended.At approximately 0300, the patient was transferred to the orthopedic unit from the emergency room and the device was programmed to deliver hydromorphone 30mg/30ml.No specific programming parameters were provided.At that time, the nurse reported difficulty inserting the syringe into the device and the device did not recognize the barcode on the syringe.After successfully inserting the syringe, the tubing set was connected to the patient's iv site and the nurse continued to purge the tubing set 2 times with an unspecified volume of medication.The patient was instructed by the nurse on the use of the device and the delivery was started.At approximately 0315, the nurse found the patient unresponsive.At 0320, a code was called.At that time, it was reported the patient was called.At that time, it was reported the patient was apneic, bradycardic, cyanotic and with a sp02 of 50%.The patient was treated with oxygen, narcan 0.4mg iv times 4 doses for a total of 1.6mg and was intubated.The patient remained unresponsive and was transferred to the icu (intensive care unit).The device was removed from clinical service.The customer contact reported a volume of 13ml remained in the vial instead of a unspecified volume expected to be remaining.The patient remained ventilated and sedated with an unspecified concentration of propofol at a rate of 19ml/hr.At approximately 0915, the patient was extubated.The patient was reported to fully recover, had an unspecified ankle surgery as expected and was discharged home within 2 days.The customer reported, "there is a possibility that this was a programming error." no additional information was provided.

Manufacturer Narrative

The device was received.Investigation is not complete.The device history was downloaded at the service center.A review of the device history on the reported event date of (b)(6)2015 at 0302 indicated the history was cleared.Between 0302 and 0305, 8 check injector and check syringe alarms occurred, the door was locked and opened x1.Between 0306 and 0307, hydromorphone 1mg/ml was confirmed and cca moderate dose was selected, purge x2, check syringe, check injector alarm, check vial alarm, the door was locked and a check settings alarm occurred.At 0308, the door was opened and the device was programmed, pca only mode, 0.3mg patient initiated pca dose occurred.At 0525, the door was opened, a check vial, check syringe alarm occurred, the door was locked a check settings alarm occurred, the door was opened.At 0526, the device was powered off.A review of the device history indicated the device delivered as programmed.This report represents all the information known by the reporter upon query by hospira personnel.

Manufacturer Narrative

The device passed testing for delivery accuracy.During testing using the customer's provided tubing set and vial, the device delivered a measured volume of 20.4ml, 20.4ml, and 20.2ml from an expected delivery of 20ml.Delivery accuracy for this device requires delivery of 20ml +/- 1ml (+/- 5%).The delivery accuracy test was also performed using a test vial and tubing set, the device delivered a measured volume of 20ml, 20.2ml and 20.2ml from an expected delivery of 20ml.Additional testing using the latest customer protocol found in the device history found the device delivered a measured volume of 30ml from an expected delivery of 30ml.During testing no air was noted in the vial or tubing set.The customer' s reported event of over delivery was not duplicated during testing.No probable cause was found.

• Brand Name: LIFECARE PCA 3 V5.06
• Type of Device: 80MEA
• Manufacturer (Section D): HOSPIRA COSTA RICA LTD.; zona franca global; la aurora de heredia, cri
• Manufacturer (Section G): HOSPIRA COSTA RICA LTD.; zona franca global; la aurora de heredia, cri
• 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: 4855485
• MDR Text Key: 5874635
• Report Number: 9615050-2015-01119
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 20709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2006
• 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: PCA TUBING SET, LIST #14279, LOT #UNK,; MANUFACTURED BY HOSPIRA, INC.; MANUFACTURED BY PHARMIDIEN.
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 51 YR