MAUDE Adverse Event Report: HOSPIRA COSTA RICA LTD. LIFECARE PCA 3 V5.06; PUMP, INFUSION

Catalog Number 20709

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

Patient Problem Death (1802)

Event Date 03/03/2013

Event Type  Death  

Event Description

Documents received from the reporter alleged that a hospira pca device was in use at the time of the patient's death.No specific patient information, pump programming, or event details were provided.The documents state that there was no indication the device malfunctioned, and the customer contact indicated that the formal cause of death was natural causes.However, the documents state that the patient's family have alleged there may be an issue with the device that resulted in an alleged over delivery of medication.Though requested, no additional information was provided.

Manufacturer Narrative

The device was not identified by serial number; the customer contact reported it will not be returned for investigation.The device was not returned to hospira for testing and investigation; therefore, attribution of the issue to the device could not be determined.This report represents all the information known by the reporter upon query by hospira personnel.

Manufacturer Narrative

Subsequent to the submission of the initial medwatch report, additional information was received including the date of the event and the device serial number.

Event Description

On (b)(6) 2013 the patient had a uncomplicated laparoscopic cholecystectomy and cholangiograms.It was reported, that on (b)(6)2013 the patient presented to the emergency room with the complaints of abdominal pain, female abdominal pain, nausea, urinary retention, back pain, shortness of breath, trouble breathing, and/or chest pain.The patient was admitted (b)(6) 2013 to the hospital to hydrate, perform blood tests, imaging scans, place on a pain administration device and continue home meds.The patient was prescribed medication for management of pain, nausea, itchiness, and insomnia.A sleep apnea assessment was completed and the patient was found to be at high risk.The patient was given a pca pump, no programming parameters were provided.It was reported that on (b)(6) 2013 the nurse administered 2 boluses of hydromorphone in addition to the pca administration of hydromorphone.On (b)(6) 2013 at around 0500 an unknown health care worker entered the patient room to collect a blood sample at found the patient unresponsive.A code blue was called and despite rescue efforts the patient remained unresponsive and was pronounced deceased at 0529.An autopsy was completed and revealed that the patient died of acute intoxication due to the combined effects of hydromorphone, diphenhydramine, oxycodone, fluoxetine, forfluoxetine, trazadone, tetrahydrocannabinol, and caffeine.Hydromorphone levels were found to be at or around lethal levels.

Manufacturer Narrative

Subsequent to the submission of the follow-up #1 medwatch report, additional information was received.The device history was downloaded at the user facility.A review of the history indicated that on (b)(6) 2013 between 1729 & 1730, the device was powered on, the history was cleared, received a check injector alarm, (unspecified)drug was confirmed, no cca was set, the device was programmed and confirmed for pca only mode, with a 0.2 pca dose, a 5 minute lockout, a 2.4 one hour limit, and the door was locked.Between 1736 & 1811, there were three 0.2 pt initiated deliveries, and one unmet demand.Between 1812 & 1813, there was one unmet demand, the door was opened, a 0.3 loading dose was delivered, and the door was locked.Between 1819 & 2022, there were nineteen 0.2 pt initiated deliveries, and forty-two unmet demands.At 2027, the door was open, shift was cleared total infused 4.7, the drug library install was declined and the device was turned off.Between 2046 & 2047, the device was turned on, bar code not read alarm, new patient was not selected, check vial alarm, check syringe alarm, check injector alarm, settings were retained, set and confirmed pca only mode, with a 0.2 pca dose, a 5 minute lockout, a 2.4 one hour limit, and the door was locked.Between 2048 & 2101, there were eight 0.2 pt initiated deliveries, and three unmet demands.Between 2102 & 2103, the door was opened, a 0.3 loading dose was delivered, and the door was locked.Between 2108 & 2128, there were six 0.2 pt initiated deliveries, and four unmet demands.Between 2130 & 2131, the door was open, shift was cleared total infused 1.7, set and confirm change pca dose to 0.3, and the door was locked.Between 2134 & 2146, there were two 0.3 pt initiated deliveries, and five unmet demands.At 2147, there was one 0.3 pt initiated delivery, the dose limited was reached.Between 2148 & 2149, the door was opened, infusion resumed, a 0.4 loading dose was delivered, the dose limit was reached, and the door was locked.Between 2154 & 2200, there were six unmet demands and infusion resumed.Between 2201 & 2303, there were six 0.3 pt initiated deliveries, there were two 0.2 pt initiated deliveries due to dose limit was reached, dose limit was reached and resumed eight times and there were forty unmet demands.Between 2305 & 2308, there was one 0.3 pt initiated delivered, dose limit was reached, door was opened, set 0.8 loading dose, infusion resumed, dose limit reached, empty syringe alarm, loading dose stopped at 0.2, and the door was locked.At 2310 & 2311, the door was opened, check vial alarm, check syringe alarm, check injector alarm, setting were retained, set and confirmed pca only mode, with a 0.3 pca dose, a 5 minute lockout, a 2.4 one hour limit, a 0.6 loading dose was delivered, and the door was locked.Between 2313 & 2330, there were twenty-three unmet demands and infusion resumed.Between 2331 & 2344, there was a 0.1 pt initiated delivery due to dose limit was reached, infusion resumed, there was a 0.2 pt initiated delivery due to dose limit was reached, infusion resumed, and six unmet demands.Between 2346 & 0031, the door was opened and locked, there was a 0.2 pt initiated delivery due to dose limit was reached, infusion resumed, there was one 0.3 pt initiated delivery, dose limit was reached, infusion resumed, new day time stamp received (b)(6) 2013, there was a 0.2 pt initiated delivery due to dose limit was reached, infusion resumed, there were four 0.3 pt initiated deliveries and fifth-teen unmet demands.Between 0034 & 0042, there was an unmet demand, there was a 0.2 pt initiated delivery due to dose limit was reached, another unmet demand, infusion resumed, there was a 0.2 pt initiated delivery due to dose limit was reached, and infusion resumed.At 0048, there was one 0.3 pt initiated delivery.At 0056, there was one 0.3 pt initiated delivery.At 0102, there was one 0.3 pt initiated delivery.At 0107, there was one 0.3 pt initiated delivery.At 0114, there was one 0.3 pt initiated delivery.Between 0317 & 0318, the door was opened, shift was cleared total infused 9.3 and the door was locked.

Event Description

Documents received from the reporter allege that a hospira pca device was in use at the time of the patient's death.No specific patient information, pump programming, or event details were provided.The documents state that there was no indication the device malfunctioned, and the customer contact indicated that the formal cause of death was natural causes.However, the documents state that the patient's family have alleged there may be an issue with the device that resulted in an alleged over delivery of medication.Though requested, no additional information was provided.

• Brand Name: LIFECARE PCA 3 V5.06
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): HOSPIRA COSTA RICA LTD.; 9615050; 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 ; 275 n field drive; bldg. h2-1east, dept no. 097u; lake forest, IL 60645 ; 2242125740
• MDR Report Key: 3645483
• MDR Text Key: 4207650
• Report Number: 9615050-2014-01204
• 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: Attorney
• Type of Report: Initial,Followup
• Report Date: 01/15/2014

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 20709
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/15/2014
• Initial Date FDA Received: 02/14/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2007
• 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
• Patient Outcome(s): Death