Summary of MedSun Reports Describing Adverse Events With Patient-Controlled Analgesia (PCA) Pumps
MedSun: Newsletter #45, February 2010

A patient-controlled analgesia (PCA) pump is a computerized machine that is attached to a patient's intravenous (I.V.) line. A patient can choose when to take more pain medicine through the use of the PCA pump. The machine contains a syringe of pain medicine as prescribed by a doctor. The syringe is attached to tubing and connected directly to the I.V. line. In some cases, the pump is set to deliver a small, constant flow of pain medicine. When a patient feels pain, he or she can press the button on the pump for additional pain medicine. The machines have built-in safety features. The total amount of analgesic (pain reliever) that the patient can self-administer is within a safe limit [1].
Over the past 2 years, MedSun has received 17 adverse event reports associated with the PCA pumps that resulted in either over-infusion or under-infusion of the drug to the patient. These reports include devices manufactured by the following manufacturers: Hospira LTD (6), Baxter Healthcare Corporation (4), Sistemas Medicos Alaris (2), B. Braun Medical, Inc. (1), Cardinal Health (1), Curlin Medical (1), , IRadimed Corporation (1), and Smiths Medical MD, Inc. (1). The reports were submitted by 16 hospitals between July 2007 and July 2009.

The most frequently reported device problems were:
• Screen displayed dosage did not match dose administered to patient (4)
• Controller malfunction (2)
• Human factors (2)


No reports involved a patient death. Ten of the 17 reports were associated with over-infusion of the prescribed drug and 7 of the 17 reports were associated with under-infusion of the prescribed drug. The patient injuries listed below were reported in 8 of these 17 reports.
• Inadequate pain relief (5)
• Shallow respiration (1)
• Lethargic (1)
• Unresponsive, needed to be revived (1)

Of the reports that listed patient age, 3 had a patient age listed as less than 21 years and 9 had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 8 reports involved female patients and a total of 3 reports involved male patients.

The following table lists the MedSun reports that are described in the device problem summary above.

Adverse Events
ManufacturerBrand Model#/Catalog#/Lot# Event Description
ALARIS Medical Systems, Inc. Alaris None/None/None While instructing the patient on PCA use, I jiggled the patient controller, and heard a beep from the module. I had not touched the button, but the PCA administered a dose anyway.
Hospira Global Medical Affairs Hospira None/None/None Nurse was changing the syringe on the PCA pump. Initially, the syringe would not fit into the cartridge. As she attempted to get the syringe in, each time she made an attempt, the plunger would push medication through the tubing into the patient. What she discovered was that the cartridge had to be lifted back into position after removing the previous syringe to get this to fit into the pump. When she finally had gotten the syringe properly in place, the patient was lethargic and nearly unresponsive. She noted that a significant amount of medication had inadvertently been administered. The clamp on the tubing was not closed before adding the new medication. This is a new pump and this is a change in process for the staff. This was not included in the training by the manufacturer.
Hospira Global Medical Affairs Abott Lab 4100 4100/None/None Screen displayed usage of 0.8mg. However, upon measurement of syringe, patient possibly used 15-17mg.
Hospira Global Medical Affairs Abbott Lab 4100 4100/None/None Per machine, the patient received 0.8mg Dilaudid but, upon RN inspection, it was measured as 12mg. Pt received the wrong dose of the medication.
Curlin Medical Inc. curlin medical pca pump 203258/None/None Pt. complaining of pain. It was not well controlled. Pt. controlled bolus was not being delivered. A different pump was tried, but the same issue occurred. Biomed was called and the PCA button and cord were replaced. The patient bolus was then delivered.
Baxter Healthcare Corporation None IPUMP/None/None An Epidural Pump was placed on the patient after surgery. The unit was started in the evening with a rate of 10 ml of continuous flow with no bolus given. The unit appears to be delivering the medication, but the patient reported that the pain would not subside. Alternative pain medication was given since the patient was in obvious pain. The anesthesiologist checked the unit the next morning (~11 hrs later) and noted that no medication had been given. However, the unit indicated that 229 ml has been delivered. The epidural pump was pulled from service and another unit was used with the same tubing. The unit was tested by Biomedical Services on the same settings and tested fine. The pump will be sent to the manufacturer for further evaluation.
Cardinal Health Alaris 8015/None/None 55 ml Fentanyl syringe delivering 4 ml/hr (200mcg/hr) syringe was started and approximately 2.5 hours later, the syringe was found to be almost empty. Patient stable post event. Biomedical Assessment: Problem: Reported problem says: 60ml Fentanyl syringe set to deliver at 4ml/hr started and approximately 2.5 hours later the syringe was empty. The drug infused too quickly. It should have taken 15 hrs to deliver 60ml's. Corrective Actions/Recommendation: The event log from the PCA module shows that it was set to deliver 20 ml/hr instead of the 4 ml/hr as indicated by the nurse. There were no errors in the error logs for either the PCU or the PCA module. The pump functioned properly, but was set at the wrong rate.
B Braun Medical Inc. Patient Controlled Analgesia Pump None/None/None Pt.complained of not getting relief from PCA medication. RN realized that most of the medication was still in the bag. Further assessment revealed that the PCA button was not working(i.e. when pushed pt did not receive bolus). Biomedical engineering tested the pump and identified a broken cable as the source of the problem. This has been a frequent problem with these pumps. Biomed believes the cable should be designed to be more flexible. We are also reminding our staff not to tightly wrap the cords for storage.
Baxter Healthcare Corporation Baxter PCA Pump None/None/None Syringe check indicated substantial amount of medication left in syringe. PCA machine evaluated. Although PCA machine indicated it was running and giving appropriate amounts of attempted injections, found PCA machine was not injecting.
IRadimed Corporation IRADIMED None/None/None IRADIMED pump noted to be delivering prescribed bolus infusion over 3 minutes instead of 10 minutes as programmed.
ALARIS Medical Systems, Inc. Medley 8120/None/None A pediatric patient was being infused with 0.2mg/ 1 mL concentrated Dilaudid from an Alaris Patient Controlled Analgesic (PCA) pump. At approximately 2200 it was noted that the patients respiration rate was shallow (less than 5 breaths/min) with periods of apnea. The oxygen saturation (SpO2) was 77%. The patient was arousable, but having difficulty staying awake. The patient was placed on 2 lpm oxygen and the PCA was withheld. The resident physician was notified. The PCA was changed to an 8 minute lockout cycle (was previously programmed at a 6 minute lockout). The patient continued to have a shallow respiration rate. The resident was updated and assessed the patient. The PCA was discontinued and Narcan was administered. The patient respiration rate increased to around 18 breaths/min, and the SpO2 increased to 98.1%. Lortab was administered at this time. Biomedical Engineering was notified, and the infusion pump PCU and PCA module were tagged and removed from the unit for inspection, and an alternative pump was obtained for the patient. After the incident took place, another RN on the unit instructed the RN that observed the incident to verify the PCA was programmed correctly. Two RNs went to verify the programming of the PCA and noted that it had not been programmed correctly. The PCA was programmed using the 0.1mg/ 1mL concentration of Dilaudid rather than the actual 0.2mg/ 1mL concentration stated on the syringe label. The delivery rate was programmed at 0.1 mL for every PCA dose with a 6 minute lockout cycle, so the patient was actually receiving 0.02 mg of Dilaudid with each PCA dose, when only 0.01 mg was ordered. The PCA programming was corrected at this time and the patient improved with no permanent harm noted. Biomedical and Clinical Engineering reviewed the PCA and infusion pump event logs, and verified that on the day of the event (midnight), the PCA was programmed for 0.1mg/ 1mL concentrated Dilaudid. The syringe was labeled as 0.2mg/ 1mL concentration. The concentration was not changed again until approximately 0100 the following day. Therefore, the patient was receiving twice the ordered dose of Dilaudid for an approximate 24-hour period of time. This incident is determined to be a use-error. The patient was given twice the ordered dose of Dilaudid due to an error in programming of the drug concentration on the PCA pump. The patient was stabilized and no further injury occurred. The Alaris PCA and infusion pump were thoroughly examined by Biomedical Engineering after the incident and no damage or malfunction was found.
Baxter Healthcare Corporation AP2 2L3105R/None/None A Baxter AP2 PCA pump was removed from a "do not touch" box in the Materials Department, and used on patient who was on a ventilator and sedated for medication administration. The hospital does not use this pump anymore. The pump was reading low volume, so the ICU nurse went to change the bag and noticed that the bag was almost full. It was programmed for an 8 cc/hr dosage, but and only 35 cc infused in 23 hour period.
Hospira Global Medical Affairs LifeCare None/None/None The patient became unresponsive with hemodynamic instability. Initially, there was 22 ml in the syringe. An hour and 15 minutes later, there was only 7 ml in the syringe. The patient was unresponsive and was revived with Norepinepherine, Narcan and Lasix. The patient was successfully revived and is currently fine.
Hospira Global Medical Affairs Lifecare None/None/None The patient's medication was ordered, which was Fentanyl PCA 1500 mcg/30ml: 25 mcg per request q5 minutes, 600 mcg/4 hour lockout. The incorrect concentration was programmed into the pump. The syringe was filled with Fentanyl at a concentration of 50 mcg/ml, however the pump was programmed for a concentration of 25 mcg/ml. The patient received twice as much drug as prescribed. He had excellent pain control and was feeling fine (he is opiate-tolerant). In review of the pump history, it was noted that the pump settings were checked and verified at the incorrect (25 mcg/ml) concentration five different times in the previous 24 hours. This is a high alert medication, and the two nurse safety check on the programming was not performed. This syringe comes in an empty vial, which requires nursing to program the pump with the dose concentration. The pharmacy does not have the technology in place to print barcodes for empty vials that are filled. Additionally, this product is not available commercially in pre-coded vial that will fit in the Hospira pump.
Hospira Global Medical Affairs Lifecare 39385/None/None PCA pump did not alarm occlusion and was clamped for an extended amount of time resulting in the patient not recieving proper/ordered medication for pain management.
Smiths Medical MD, Inc. CADD Prizm PCS II CADD Prizm PCS II/None/None Pt with PCA for abdominal pain. Pump settings in AM were: Hydromorphone 0.2 mg/ml. 50 doses in the container to start with no basal dose, and demand dose of 0.2 mg. Lockout time 10 minutes, with 41.7 mg in the container. Later that evening, it was determined there was a discrepancy with the remaining amount in container vs. what pump indicated had been infused. Pump stated reservoir had 24.4 mg remaining after 0.4 mg given. Previously, in the AM, there was 41.7 mg in the reservoir. So, there is a discrepancy of approximately 16 mg. Patient had made 10 attempts. Pump settings were verified. Pt had complained that she had not received adequate pain relief.
Baxter Healthcare Corportation I Pump None/None/None The nurse reported that the Narcotic I pump was not keeping the programmed amount and kept shifting back to previously set settings. In addition, the pump was not maintaining an appropriate history of the amount infused, and then kept alarming "malfunction". It was also noticed the pump kept increasing the amounts for medication to maintain sedation. This unit is not owned by our hospital, it is leased equipment through a separate company. The pump was sent out to the rental company for repairs.




Additional Information:

[1]. Cleveland Clinic. (2009). Patient-Controlled Analgesia (PCA) Pump. Retrieved July 28, 2009, from Cleveland Clinic Foundation Website:
http://my.clevelandclinic.org/services/pain_management/hic_pain_control_after_surgery.aspx


MedSun Newsletters are available at www.fda.gov/cdrh/medsun