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

Model Number 8110

Device Problems Excess Flow or Over-Infusion (1311); Use of Device Problem (1670)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 04/10/2023

Event Type  malfunction  

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 the syringe pump was infusing epinephrine at 1.8ml/hr.Contained in a "50(60)ml bd luer lock syringe" on (b)(6) 2023.At 0505, the syringe pump alarmed ¿syringe empty¿ alarm and reportedly did not alarm ¿near end¿ (near end of infusion or neoi) prior to that.According to the customer, the pumps in pediatric intensive care unit as set to alarm for neoi at five (five) minutes for both continuous and intermittent infusions.The clinician reported that prior to this event, the infusion had "more than five hours' worth of epinephrine left." due to the event, the clinician "made and hung a new syringe." the clinician then proceeded to "prime the epinephrine line again." the clinician reportedly did not use the device's prime set with syringe feature and "rather appeared to be priming it at a rate of 999" (manually).Upon looking at the pump, a full 2ml had been primed during this time.It was unclear whether or not the tubing was connected to the patient during priming.The customer would like to know what "exactly what was done with the epinephrine between 0330 and 0500" and the customer also stated, "we are trying to decipher the different account each nurse is reporting and whether alarms rang, how infusions were started etc." it was also reported that the patients¿ blood pressure "was reflective of having received a bolus at the time of priming." systolic blood pressure "went as high as 117 when it had been sitting consistently between 70-80 on the epinephrine infusion." there was patient involvement and according to the nurse manager, there was no harm to the patient.

Manufacturer Narrative

Omit : b17 - device not returned, c20 - no findings available, d15 - cause not established.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.H3 other text : not applicable.Device evaluated by bd.

Event Description

It was reported that the syringe pump was infusing epinephrine at 1.8ml/hr.Contained in a "50(60)ml bd luer lock syringe" on (b)(6) 2023.At 0505, the syringe pump alarmed ¿syringe empty¿ alarm and reportedly did not alarm ¿near end¿ (near end of infusion or neoi) prior to that.According to the customer, the pumps in pediatric intensive care unit as set to alarm for neoi at five (five) minutes for both continuous and intermittent infusions.The clinician reported that prior to this event, the infusion had "more than five hours' worth of epinephrine left." due to the event, the clinician "made and hung a new syringe." the clinician then proceeded to "prime the epinephrine line again." the clinician reportedly did not use the device's prime set with syringe feature and "rather appeared to be priming it at a rate of 999" (manually).Upon looking at the pump, a full 2ml had been primed during this time.It was unclear whether or not the tubing was connected to the patient during priming.The customer would like to know what "exactly what was done with the epinephrine between 0330 and 0500" and the customer also stated, ".We are trying to decipher the different account each nurse is reporting and whether alarms rang, how infusions were started etc." it was also reported that the patients¿ blood pressure "was reflective of having received a bolus at the time of priming." systolic blood pressure "went as high as 117 when it had been sitting consistently between 70-80 on the epinephrine infusion." there was patient involvement and according to the nurse manager, there was no harm 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 (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: 16893720
• MDR Text Key: 314840472
• Report Number: 2016493-2023-159646
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403811043
• UDI-Public: (01)10885403811043
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K133532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8110
• Device Catalogue Number: 8110 ALARIS SYRINGE MODULE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2022
• 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.; 8100.
• Patient Age: 3 YR
• Patient Sex: Male