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

Model Number 8100

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Sedation (2368); Lethargy (2560)

Event Date 10/25/2019

Event Type  Injury  

Manufacturer Narrative

Weight requested, however was not provided.The reported issue of a magnesium sulfate over infusion with a recorded volume infused at 638.665 ml was confirmed.Maintenance ivf was infusing on channel a at 75 ml/h.Magnesium sulfate was infusing on channel b at 50 ml/h following completion of a bolus dose with vtbi at 150 ml.Infusions were stopped after a power interruption occurred to the channel a and channel b pump modules, inducing a ¿channel disconnected¿ alarm on the pcu.Following confirming of the ¿channel disconnected¿ alarm on the pcu, the channel b pump module was manually reprogrammed to infuse a basic infusion at the rate of 75 ml/h; however if could not be ascertained from the log if a new bag had been changed or the maintenance ivf moved to the channel b pump.The channel a pump was manually reprogrammed to infuse magnesium sulfate at the default rate of 50 ml/h; however if could not be ascertained from the log if a new bag had been changed or the magnesium sulfate moved to the channel a pump.In addition the channel b pump rate was then increased to 999 ml/h a few minutes later.Both the channel a and b pump modules were turned off at 11:52 and 11:57am respectively with the channel b pump module having a recorded volume at 638.665 ml.The inspection found the left iui connector on the pcu had contact pins with contamination and corrosion present.This was also found with the interfaced right iui connector on the pump module attached to the pcu left iui connector making either of these connectors potentially the source for the incident.The testing did not replicate the event as recorded; however it produced a channel disconnected alarm event with power loss to the channel a pump module only.This module also had a right iui connector with pins having contamination and corrosion present.Temporary replacement of the right iui connector resulted in not reproducing the alarm during repeated testing.The fact that the ¿channel disconnected¿ alarm incident could not be replicated as recorded can be attributed to the inherent wiping action of the iui connection pins during removal and attachment.This most likely had removed or displaced the interfering contaminate outside of the contact area of the pin(s).The root cause for the over infusion was suspected to be the result of unintended swapped reprogramming between the two pump modules channels a and b following a ¿channels disconnected¿ alarm that was induced when the noted pump modules had their power interrupted while infusing.The root cause for the power interruption to the modules is being attributed to iui connectors that are over 8 years old with contamination and corrosion found present on the pins.

Event Description

It was reported that, at 1042 the patient was given a magnesium sulfate 40 g/1000 ml loading dose to infuse at 300 ml/hr.For the duration of 30 minutes.After completion of the loading dose the infusion was to revert to a continuous rate of 50 ml/hr.Upon review, it was found that the device displayed the volume infused was 638.665 ml when the actual amount infused was 600 ml.It was reported the patient became somnolent.Upon arrival of the pharmacist it was noted that there was a greater dose missing from the bag than what should have been infused during that time frame.The magnesium bag was a premix bag, not one that was compounded by the hospital.A magnesium antidote was given with a positive response.

Event Description

It was reported that at 1042 the patient was given a magnesium sulfate 40g/1000ml loading dose to infuse at 300ml/hr.For the duration of 30 minutes.After completion of the loading dose the infusion was to revert to a continuous rate of 50ml/hr.Upon review, it was found that the device displayed the volume infused was 638.665ml when the expected amount infused was 600ml.It was reported the patient became somnolent.Upon arrival of the pharmacist, it was noted that there was a greater dose missing from the bag than what should have been infused during that time frame.The magnesium bag was a premix bag, not one that was compounded by the hospital.A magnesium antidote was given with a positive response.

Manufacturer Narrative

The customer reported that there was a greater dose missing from the bag than what was expected.Analysis of the log file determined that subsequent to channel disconnect alarms, the original programming of channels a and b was reversed.

• 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: 9340709
• MDR Text Key: 167406020
• Report Number: 2016493-2019-01521
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403810015
• UDI-Public: 10885403810015
• Combination Product (y/n): N
• PMA/PMN Number: K950419
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (2)8100,8015,(3)PRI TUBING,8300,8120, TD (B)(6) 2019
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR