MAUDE Adverse Event Report: CAREFUSION ALARIS PCA PUMP TUBING; SET, ADMINISTRATION, INTRAVASCULAR

Model Number PCA TUBE

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem Hypoxia (1918)

Event Date 10/30/2019

Event Type  Injury  

Manufacturer Narrative

Report source: csc product recovery specialist.No product will be returned per customer.The customer complaint could not be confirmed because the device/product was not returned for failure investigation.The root cause of this failure was not identified.The customer stated that the patient was an infant.

Event Description

It was reported that the infant patient was noted to have an increased fio2 requirement and increased transcutaneous monitoring (tcms) in the beginning of the shift at approximately 0700.A fentanyl bolus was administered from the bag at approximately 0945.At approx.1020 the alaris pump alarmed "air in line".Upon assessment, it was noted that there was a significant amount of air in the tubing.The infusion was paused, the tubing set clamped when the nurse began to "flick" air out of the tubing.When the tubing set was "flicked", fentanyl leaked out of a hole near the upper fitment.The md was notified and at 1045 a one time fentanyl syringe bolus was ordered due to the infant not receiving the correct fentanyl dosage for an unknown period of time.The bolus was given at approximately 1045.Pharmacy was notified and a new fentanyl bag was delivered and hung at approximately 1105 and the infant's fio2 requirement and tcms were noted to have decreased during the 12:00 vitals.There were no lasting adverse effects caused to the infant due to the event.The customer stated that there is no further event information available.

• Brand Name: ALARIS PCA PUMP TUBING
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 9787297
• MDR Text Key: 188361835
• Report Number: 9616066-2020-00637
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PCA TUBE
• Device Catalogue Number: PCA TUBE
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention