MAUDE Adverse Event Report: CAREFUSION SD ALARIS SYSTEM; PUMP, INFUSION

Model Number 8015

Device Problems Thermal Decomposition of Device (1071); Mechanics Altered (2984)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/03/2024

Event Type  malfunction  

Event Description

It was reported that a fire occurred from the 3-prong electrical plug of the pc unit.The device was plugged directly into the ac wall outlet.The fire reportedly occurred at the junction of the power cord and the outlet.The cord had been plugged into the outlet for approximately 30 minutes before the fire began.When asked, the customer stated that they did not find evidence of extraneous material that came into contact with the power cord.It was also reported that the hospital's electrician noted that the ac outlet burning "was mostly superficial to the outlet and that the wires feeding the outlet were undamaged." there was patient involvement but no harm.

Manufacturer Narrative

A follow up report will be submitted with investigation results should the device be repaired or the device/logs be received for evaluation.Per 803.52(f)(11)(iii) the information provided represents all of the known information at this time.The complainant or reporter was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer.Device was not returned to manufacturing facility.

Event Description

It was reported that a fire occurred from the 3-prong electrical plug of the pc unit.The device was plugged directly into the ac wall outlet.The fire reportedly occurred at the junction of the power cord and the outlet.The cord had been plugged into the outlet for approximately 30 minutes before the fire began.When asked, the customer stated that they did not find evidence of extraneous material that came into contact with the power cord.It was also reported that the hospital's electrician noted that the ac outlet burning "was mostly superficial to the outlet and that the wires feeding the outlet were undamaged." there was patient involvement but no harm.A copy of the medwatch report from fda was received, which states, ¿alaris pc unit 8015 had electrical fire on three prong plug while in use in icu.Electrical short where, the 3-prong plug was caused fire to start.Nurse noticed issue and called for fire.Sedated and ventilated patient was relocated to another room.Patient was respirated with a manual bag.Resuscitator while the patient was moved to a new room and connected to a ventilator.Electrical plug was removed from wall by grasping cord from a distance.Hot and neutral prongs were left behind in receptacle.Fire extinguisher used to extinguish flame.Patient in adjacent room bed 15 was later relocated due to smoke and extinguishant in the air.No apparent harm to patient.Patient and infusion pump had returned from ctscan 30 minutes prior.Nurse did not notice any unusual about plug (bent or loose pins) when she plugged the infusion pump into the receptacle.".

Manufacturer Narrative

Omit : b17 - device not returned, c20 - no findings available, d15 - cause not established.Additional information : device available for eval?, returned to manufacturer on, report source, device return to manuf.?, device eval by manufacturer?, if other specify, imdrf annex a, b, c, d, g codes and manufacturer narrative.A device history record review is performed on each device reported in a mdr reportable event along with other methods of investigation as coded in section h6 of this mdr report.

• Brand Name: ALARIS SYSTEM
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: brett wilko ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 18594316
• MDR Text Key: 333899164
• Report Number: 2016493-2024-11259
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403801518
• UDI-Public: (01)10885403801518
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8015
• Device Catalogue Number: 8015 ALARIS PCU 1.5 MODULE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2013
• 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