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

Model Number 8100

Device Problem Insufficient Information (3190)

Patient Problems Convulsion/Seizure (4406); Insufficient Information (4580)

Event Date 10/11/2021

Event Type  Injury  

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 this mdr report.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.Although requested, product has not been received.

Event Description

It was reported that an infusion of total parenteral nutrition (tpn) was ordered and programmed at 2200 to run over 24 hours through peripherally inserted central catheter (picc).The tpn rate was set at 20ml/hr with a total volume of 450ml.The baby was sleeping and checked 20 minutes later.At 2345, the baby was found seizing.The physician was immediately called to the bedside.The tpn tubing was found dry and the entire bag was infused in over 2 hours although the pump recorded it had delivered 44ml.The patient required additional care as a result of this incident.

Event Description

It was reported that an infusion of total parenteral nutrition (tpn) was ordered and programmed at 2200 to run over 24 hours through peripherally inserted central catheter (picc).The tpn rate was set at 20ml/hr with a total volume of 450ml.The baby was sleeping and checked 20 minutes later.At 2345, the baby was found seizing.The physician was immediately called to the bedside.The tpn tubing was found dry and the entire bag was infused in over 2 hours although the pump recorded it had delivered 44ml.The patient required additional care as a result of this incident.The customer then reported that the involved alaris devices were sent to a third party (ecri institute) for evaluation.Received a copy of the customer's sus voluntary event report from fda which states, ¿ alaris pump was programmed appropriately via the interop function (within epic) to deliver 20ml/hr tpn to the patient.The patient began seizing and it was discovered that the entire 480ml of tpn was empty.Pump settings rate was verified at correct rate of 20ml/hr(per md order).Another nurse verified that pump was set correctly, however the bag was dry.It appears the pump malfunctioned and infused 24 hours of tpn in 2 hours.The patient received pharmacologic intervention, imaging, ng tube and was transferred to the intensive care unit.The pump has been sent to bd for interrogation as there does not appear to be any human or epic error involved upon in-depth review of this event.Of note, this was one of three similar events submitted within 60 hours at our same facility.I have submitted medwatch events for those as well".There was serious injury to the patient.

• Brand Name: ALARIS SYSTEM
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): 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: 12696501
• MDR Text Key: 278332159
• Report Number: 2016493-2021-66815
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403810015
• UDI-Public: (01)10885403810015
• 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: Other,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• 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 ALARIS LVP MODULE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2015
• 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
• Treatment: 8015; 8015
• Patient Outcome(s): Required Intervention
• Patient Age: 3 MO