MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP MODULE; PUMP, INFUSION

Model Number 8100

Device Problems Excess Flow or Over-Infusion (1311); Human-Device Interface Problem (2949); Inadequate User Interface (2958)

Patient Problems Inadequate Pain Relief (2388); Diaphoresis (2452); Respiratory Failure (2484); Cognitive Changes (2551)

Event Date 06/30/2019

Event Type  Injury  

Manufacturer Narrative

No device will be returned per customer.The customer complaint could not be confirmed because the device was not returned for failure investigation.The root cause of this failure was not identified.Additional patient information: diagnosis; small bowel obstruction.

Event Description

It was reported that the patient was extubated at 10:40 a.M.And was receiving a fentanyl 1250mcg/250ml infusion programmed at a rate of 25mcg/hour in the critical care department.At 10:43 a.M.The rn increased the fentanyl dose to 50mcg/hour due to the patient's continued complaint of pain.At 11:47, the rn reprogrammed the device with the intent to decrease the dose to 25mcg/hour, but instead programmed the device for the fentanyl to infuse at 25ml/hour (10mcg/ml).The patient became somnolent, diaphoretic with altered level of consciousness and breathing was slow to none at all; which required the patient to be reintubated at 12:10.

• Brand Name: ALARIS PUMP MODULE
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 8843941
• MDR Text Key: 152763160
• Report Number: 2016493-2019-00904
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950419
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8100
• Device Catalogue Number: 8100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/17/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 71 YR