ALARIS PC *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-09-19 for ALARIS PC * manufactured by Cardinal Health.

Event Text Entries

[21752377] Patient had iv fluids with pca (patient controlled analgesia) continuous and an antibiotic running. Patient started having increased pain and mother of the patient requested that the nurse call the physician to have his pain medication increased. Nurse obtained the order from the hem/onc team to increase it. When two rn's went into the patient's room to change the pca settings they found that the volume infuser brain was on and the fluids were running on the right side of the pump, but the pca and patient's syringe pump with the antibiotic was turned off. Both rn's determined from the history on the pump that it had been off for approximately 1 hour and 45 minutes. When one of the rn's squeezed the brain and the pca pump together, it would light up. As soon as the other rn would let off, it would shut off again. Physician was notified and order received for one time bolus. We have had this type of issue with this device previously; however, we are not seeing a trend. The pumps are cleaned first with organosol and then with cavicide. Staff that cleans the equipment uses a toothbrush on the metal connections to ensure that they are clean and free from scale/deposits. This particular pca had a new battery replaced in the spring and has passed all of its preventative maintenance checks. The most recent preventative maintenance check on the pca was performed approximately 3 months before the event. Per biomed, we have had no trends with device connections. Biomed believes that the device may not have been plugged in or connected properly to the brain. Biomed staff were unable to reproduce the problem and has released the pca unit back into use.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2759727
• MDR Report Key: 2759727
• Date Received: 2012-09-19
• Date of Report: 2012-09-19
• Date of Event: 2012-08-10
• Report Date: 2012-09-19
• Date Reported to FDA: 2012-09-19
• Date Added to Maude: 2012-09-26
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: ALARIS PC
• Generic Name: PUMP, INFUSION, PCA
• Product Code: MEA
• Date Received: 2012-09-19
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CARDINAL HEALTH
• Manufacturer Address: 10020 PACIFIC MESA ROAD SAN DIEGO CA 92121277 US 92121 2772

Device Sequence Number: 2

• Brand Name: ALARIS
• Generic Name: PUMP, INFUSION
• Product Code: FRN
• Date Received: 2012-09-19
• Model Number: CAREFUSION
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: CARDINAL HEALTH
• Manufacturer Address: 10020 PACIFIC MESA ROAD SAN DIEGO CA 92121277 US 92121 2772

Device Sequence Number: 3

• Brand Name: ALARIS
• Generic Name: PUMP, INFUSION, SYRINGE
• Product Code: FIH
• Date Received: 2012-09-19
• Model Number: ALARIS SYRINGE
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: CARDINAL HEALTH
• Manufacturer Address: 10020 PACIFIC MESA ROAD SAN DIEGO CA 92121277 US 92121 2772

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-09-19