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

Model Number 8100

Device Problems Excess Flow or Over-Infusion (1311); Free or Unrestricted Flow (2945)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Brain Injury (2219)

Event Date 11/23/2020

Event Type  Death  

Manufacturer Narrative

Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.Patient diagnosis: motor vehicle crash resulting in subdural hematoma, subarachnoid hemorrhage, pneumothorax, & pneumomediastinum.Although requested, date of death was not provided.

Event Description

It was reported the pump was set up for a propofol infusion using the drug library at 10mcg/kg/min with a programed weight of 80kg resulting in a rate of 4.8ml/hr.This was confirmed and witnessed by other rns in the emergency department as well.After 10-15 min one of the rns observed the propofol to be dripping much faster than it should in the drip chamber and over half of the 1000mg/100ml bottle of propofol was gone.The tubing set was immediately clamped and disconnected from the patient.This resulted in a hypotensive event for the patient.Due to systolic hypotension in the 70's from the large unintended bolus of propofol received, the propofol infusion was stopped, and the patient received iv fluids and packed red blood cells.The patient had a severe head injury, multi-system trauma from a motor vehicle accident.Neurosurgery was performed due to the head injuries the patient had from the mva.It is unclear if the hypotensive event as a result of the propofol bolus had an effect on the patient's outcome.The patient outcome was deceased due to brain death resulting in withdrawal of life support.Although requested, date of death was not provided.

Event Description

It was reported the pump was set up for a propofol infusion using the drug library at 10mcg/kg/min with a programed weight of (b)(6) resulting in a rate of 4.8ml/hr.This was confirmed and witnessed by other rns in the emergency department as well.After 10-15 min one of the rns observed the propofol to be dripping much faster than it should in the drip chamber and over half of the 1000mg/100ml bottle of propofol was gone.The tubing set was immediately clamped and disconnected from the patient.This resulted in a hypotensive event for the patient.Due to systolic hypotension in the 70s from the large unintended bolus of propofol received, the propofol infusion was stopped, and the patient received iv fluids and packed red blood cells.The patient had a severe head injury, multi-system trauma from a motor vehicle accident.Neurosurgery was performed due to the head injuries the patient had from the mva.It is unclear if the hypotensive event as a result of the propofol bolus had an effect on the patient's outcome.The patient outcome was deceased due to brain death resulting in withdrawal of life support.Although requested, date of death was not provided.

Manufacturer Narrative

The report that the propofol was observed to be dripping in the drip chamber much faster than it should, and over half of 1000 mg/100 ml infused earlier than expected, was not reproduced during investigation.Inspection: initial inspection found that the lower hinge bracket was broken.The internal inspection found no issues relevant to the reported incident.The mild corrosion and contamination found on the pins of the left and right iui were not causal to the reported incident.All parts inspected were observed to be bd parts.Log analysis: review of the pcu error log found no errors or malfunctions relevant to the reported complaint on the reported date and time.Review of the pcu event log showed that on (b)(6) 2020 at 05:14:28 am, propofol (drug id (b)(6)) was selected from the guardrails drugs.The user selected the therapy type of ¿hh only¿ and a concentration of 1000 mg/100 ml with a patient weight of (b)(6) kg.The user entered a dose of 10 mcg/kg/min, which automatically programmed a calculated rate of 4.8 ml/h.The user manually entered a vtbi of 100 ml.The pvi at this time was 0 ml.The calculated duration for this continuous infusion was 20 hours 50 minutes.At 05:14:54 am, a bolus dose was programmed to infuse at a rate of 120 ml/h with a vtbi of 1.5 ml.The pvi at this time was 0.008 ml.At 05:15:40 am, the bolus dose completed and the programmed continuous infusion at a rate of 4.8 ml/h and vtbi of 98.492 ml continued to infuse.The pvi at this time was 1.529 ml.At 05:22:25 am, the pump module alarmed for patient side occlusion.The pvi at this time was 2.048 ml.At 05:23:21 am, a channel disconnect occurred.At 05:23:22 am, the pump module was removed.The pvi at this time was 2.048 ml.At 05:29:34 am, pcu sn (b)(4) was powered down.The recorded total volume infused from the specified time of 05:00 am to 07:00 am on (b)(6) 2020 was 2.048 ml.Testing: rate accuracy testing found the pump module to be delivering fluids within specification.The pump module passed rate accuracy testing with a broken lower hinge bracket.Root cause/conclusion: the probable cause of the propofol dripping in the drip chamber much faster than it should, resulting in over half of the 1000 mg /100 ml being infused earlier than expected, was determined to be a broken lower hinge bracket on the platen assembly.A broken lower hinge bracket may result in a lack of mechanical interference (fit) between the platen and the occlude, and will inhibit the ability of the pumping mechanism to act on the tubing set within rate accuracy specifications, or cause unregulated flow, which may primarily lead to an over infusion.Previous investigations have shown that devices with a broken lower hinge bracket may result in the platen assembly being out of alignment and prevent the device from delivering an accurate amount of fluid flow through the pump cycle.The probable cause of the broken lower hinge bracket is the door being forcefully closed while an external object is lodged between the platen and bezel.The bd alaris recall notification letter explains the situation wherein a broken upper hinge post, lower hinge, or membrane frame of the alaris¿ pump module may prevent the device from delivering an accurate amount of fluid, which may result in an over infusion or free-flow condition and recommends to inspect the device for broken platen elements.Device history: review of the sn (b)(4) service history record showed that the device was manufactured on 04/14/2015.A review of the device service history record was performed beginning from the date of manufacture to the present date 01/04/2020 and indicated that this device was returned on 02/08/2017 to replace the bezel assembly because of a broken lower hinge.The membrane frame and door harness were also replaced.Review of the production failure record was performed beginning from the date of manufacture through present.No production records were opened for the source device.

• Brand Name: ALARIS PUMP MODULE
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 11056339
• MDR Text Key: 241251930
• Report Number: 2016493-2020-71930
• 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: health professional,other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• 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: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2736-2020
• Patient Sequence Number: 1
• Treatment: 8015,PRI TUBING,TD: (B)(6) 2020.
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 24 YR
• Patient Weight: 80