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

Model Number 8100

Device Problems Thermal Decomposition of Device (1071); Disconnection (1171); Device Emits Odor (1425); Pumping Stopped (1503)

Patient Problems No Consequences Or Impact To Patient (2199); No Consequences Or Impact To Patient (2199)

Event Date 03/26/2019

Event Type  malfunction  

Manufacturer Narrative

No product returned.Because no device or device logs were returned or expected to be returned, no failure investigation could be performed.The root cause of the customer's experience was not identified.

Event Description

It was reported that there was a constant alarm for channel disconnect error followed by a burning smell.There were no adverse effects caused to any patients from the event.

Event Description

It was reported that there was a constant alarm for channel disconnect error followed by a burning smell.It was noted that the channel disconnects occurred after the network management net unit disconnects.There were no adverse effects caused to any patients from the event.

Manufacturer Narrative

The report of a channel disconnect error was confirmed in the pcu event log, however the report that the disconnect was followed by a burning smell was not confirmed.The pcu event log shows both pump module s/n (b)(4) and pump module s/n (b)(4) were disconnected from the system twice, at 9:44 pm and then again at 9:46 pm on (b)(6) 2019 due to loss of power.Since both devices disconnected at the same time, they could have either been both on the left side of the pcu, both on the right side of the pcu or 1 device on the left side and 1 device on the right side of the pcu.Although requested the devices were not returned for investigation, and the device iui¿s and the burning smell (thermal damage) were unable to be investigated.A review of the device error logs found no errors for the pump modules during the time of the reported event.A review of the pcu error log shows a central unit malfunction (low backup voltage failure, error code 120.4410.0) occurred at 9:50 pm on (b)(6) 2020 after the channel disconnects at 9:44 pm and 9:46 pm.This error condition is indicative of a possible thermal event occurring on one of the iui connectors.Since no product was returned for this complaint it could not be determined if a thermal event occurred.The devices were being used for treatment.The root cause of the reported channel disconnect error followed by a burning smell was not identified.Pump module serial # (b)(4): captured in manufacturer report number 2016493-2020-01144.Pump module serial # (b)(4): captured in manufacturer report number 2016493-2020-03954.Pc unit serial # (b)(4): captured in manufacturer report number 2016493-2020-03956.Device history review: review of the pcu s/n (b)(4) service history record showed the device had a manufacture date of 01 august 2013.A review of the device service history record was performed beginning from the date of manufacture to the present date 04 august 2020 and indicated that this device has not been previously returned for service.Review of the production failure record was performed beginning from the date of manufacture through present.The failure record showed no production failure records were opened for the source device.Review of the pump module s/n (b)(4) service history record showed the device had a manufacture date of 07 august 2013.A review of the device service history record was performed beginning from the date of manufacture to the present date 04 august 2020 and indicated that this device has not been previously returned for service.Review of the production failure record was performed beginning from the date of manufacture through present.The failure record showed no production failure records were opened for the source device.Review of the pump module s/n (b)(4) service history record showed the device had a manufacture date of 05 august 2013.A review of the device service history record was performed beginning from the date of manufacture to the present date 04 august 2020 and indicated that this device has not been previously returned for service.Review of the production failure record was performed beginning from the date of manufacture through present.The failure record showed no production failure records were opened for the source device.

Event Description

It was reported that there was a constant alarm for channel disconnect error followed by a burning smell.It was noted that the channel disconnects occurred after the network management net unit disconnects.There were no adverse effects caused to any patients from the event.

• 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: 10103738
• MDR Text Key: 193628585
• Report Number: 2016493-2020-01144
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403810015
• UDI-Public: 10885403810015
• Combination Product (y/n): N
• PMA/PMN Number: K133532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/08/2020

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Date FDA Received: 05/30/2020
• 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: 0
• Treatment: 8100, 8015, (2)PRI TUBING, THERAPY DATE: (B)(6) 2019