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

Model Number 8100

Device Problem No Fail-Safe Mechanism (2990)

Patient Problem Infiltration into Tissue (1931)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: 24 gauge bd insyte autoguard, or 22 gauge bd nexia diffusics.No device will be returned per customer.The customer declined to return the device for failure investigation.The root cause of this failure was not identified.The customer stated that the patient ages ranged from 5 weeks of age to 16 years of age.Males and females with varying diagnosis and medical histories.

Event Description

It was reported infiltrations occurred in the pediatric population, five of which did not require surgical intervention out of seven infiltrates.The patients ranged from 5 weeks of age to 16 years of age.Males and females were affected, and the patients had different admission diagnoses and medical history.There was no long term permanent injury that is known.The five infiltrate events captured in this file resulted in requiring an iv change.The events occurred while primary fluids were infusing and ranged from d51/2 ns with 20k, d5ns, and d5 ns and 20k.Alarms were not a factor in these events.The patient's either had a 24 or 22 gauge iv.

Event Description

It was reported infiltrations occurred in the pediatric population, five of which did not require surgical intervention out of seven infiltrates.The patients ranged from 5 weeks of age to 16 years of age.Males and females were affected, and the patients had different admission diagnoses and medical history.There was no long term permanent injury that is known.The five resulted in requiring an iv change.The events occurred while primary fluids were infusing and ranged from d51/2 ns with 20k, d5ns, and d5 ns and 20k.Alarms were not a factor in these events.The patient's either had a 24 or 22 gauge iv.

• Brand Name: ALARIS PUMP MODULE
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9655657
• MDR Text Key: 177378556
• Report Number: 2016493-2020-00149
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• PMA/PMN Number: K133532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: No
• 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 This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (5)PRI TUBING,8015,THERAPY DATE UNKNOWN